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Clinical Project Manager Salary in Sunnyvale, CA

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Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
Amazon, Sunnyvale, CA, US
DESCRIPTIONAmazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and groundbreaking devices like Fire tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical devices.Key job responsibilities• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. • Develops global regulatory strategies for new and modified products. • Prepares and submits regulatory submissions to health agencies. • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures. • Provides regulatory assessment for manufacturing, design changes and product risk assessment. • Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations. • Plans, schedules, and arranges all activities to support regulatory timelines. • Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits. • Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements. • Supports the product release process. • Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities. • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes. • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Reviews protocols and reports to support regulatory submissions. • Creates, reviews and approves engineering change requests. • Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies. About the teamThe Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.We are open to hiring candidates to work out of one of the following locations:Bellevue, WA, USA | Sunnyvale, CA, USABASIC QUALIFICATIONS- 5+ years of working directly with engineering teams experience- 5+ years of technical product or program management experience- Experience managing programs across cross functional teams, building processes and coordinating release schedules- · Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)- · Experienced in regulatory submissions for Medical Devices, In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics.- · Experience of working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).- · 5-7 years’ experience in a regulated industry with experience working with Class II and/or Class III devices.- · Ability to work effectively on project teams.- · Has a strong attention-to-detail- · Strong written, verbal, presentation, and organizational skills.- · Experience with medical device software requirements.- · Ability to identify risk areas and escalate issues as appropriatePREFERRED QUALIFICATIONS- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership- · Regulatory Affairs Certification (RAPS)- · Drug and Biologics regulatory filing experienceAmazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $119,000/year in our lowest geographic market up to $231,400/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. Applicants should apply via our internal or external career site.
Registered Nurse RN
Sunnyvale Post Acute Gardens Post Acute, Sunnyvale
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position. Administrative Functions • Assist the Director of Nursing Services in directing the day-to-day functions of the nursing activities in accordance with current rules, regulations, and guidelines that govern the long-term care facility. • Participate in developing, maintaining, and updating written policies and procedures that govern the day-to-day functions of the nursing service department. • Ensure that reference material (i.e., PDR'S, regulations, professional standards of practice, etc.) maintained at the nurses' stations is current. Recommend written material that will assist the nursing service department in meeting the day-to-day needs of the resident. • Ensure that the Nursing Service Procedures Manual is current and reflects the day-to-day nursing procedures performed in this facility. • Ensure that all nursing service personnel comply with the procedures set forth in the Nursing Service Procedures Manual. • Make written and oral reports/recommendations to the Director as necessary/required, concerning the operation of the nursing service department. • Periodically review the department's policies, procedure manuals, job descriptions, etc. Make recommendations for revisions to the Director. • Assist in developing methods for coordinating nursing services with other resident services to ensure the continuity of the residents' total regimen of care. • Ensure that all nursing service personnel are in compliance with their respective job descriptions. • Participate in the development, maintenance and implementation of the facility's quality assurance program for the nursing service department. • Participate in facility surveys (inspections) made by authorized government agencies as requested by the Administrator or Director of Nursing Services. • Periodically review the resident's written discharge plan. Participate in the updating of the resident's written discharge plan as required. • Assist the Director in planning the nursing services portion of the resident's discharge plan as necessary. • Meet with the nursing staff, as well as support personnel, in planning the department's services, programs, and activities. • Admit, transfer, and discharge residents as required. • Complete accident/incident reports as necessary. • Interpret the department's policies and procedures to personnel, residents, visitors, and government agencies as required. • Perform administrative duties such as completing medical forms, reports, evaluations, studies, charting, etc., asnecessary. • Agree not to disclose assigned user ID code and password for accessing resident/facility information and promptly report suspected or known violations of such disclosure to the Administrator. • Agree not to disclose resident's protected health information and promptly report suspected or known violations of such disclosure to the Administrator. • Report any known or suspected unauthorized attempt to access facility's information system. Committee Functions • Attend various committee meetings of the facility (i.e., Infection Control, Policy Advisory, Pharmaceutical, Quality Assessment, etc.) as required. • Assist in preparing written and/or oral reports of the nursing service programs and activities to submit to such committee(s) as directed. • Provide information to the Quality Assurance and Assessment Committee as requested. • Participate in developing the agenda for the Care Plan Committee meetings as necessary. • Participate in regularly scheduled reviews of the discharge plans and make such plans available to the Care Plan Committee as required or as may be necessary. • Implement recommendations from established committees as instructed by the Director. Personnel Functions • Ensure that a sufficient number of licensed practical and/or registered nurses are available for your tour of duty to ensure that quality care is maintained. • Ensure that a sufficient number of certified nursing assistants are available for your tour of duty to ensure that routine nursing care is provided to meet the daily nursing care needs of each resident. • Develop work assignments, and/or assist in completing and performing such tasks. • Delegate to each Charge Nurse the administrative authority, responsibility, and accountability necessary to perform his/her assigned duties. • Ensure that all nursing assistants are enrolled in or have graduated from an approved nursing assistant training program. • Ensure that all nurse aide trainees are under the direct supervision of a licensed nurse. • Make daily rounds of the nursing service department to ensure that all nursing service personnel are performing their work assignments in accordance with acceptable nursing standards. Report findings to the Director. • Monitor absenteeism to ensure that an adequate number of nursing care personnel are on duty at all times. Report problem areas to the Director. • Ensure that established policies and procedures, including dress codes, are followed by all departmental personnel. • Review complaints and grievances made or filed by department personnel. Make appropriate reports to the Director as required or as may be necessary. • Develop and maintain a good working rapport with inter-department personnel, as well as other departments within the facility to ensure that nursing services and activities can be adequately maintained to meet the needs of the residents. • Create and maintain an atmosphere of warmth, personal interest and positive emphasis, as well as a calm environment throughout the unit and shift. • Meet with your shift on a regularly scheduled basis to assist in identifying and correcting problem areas and/or to assist in the improvement of services. • Review and evaluate your department's work force and make recommendations to the Director. • Participate in employee performance evaluations, determining your shift's staffing requirements, and making recommendations to the Director concerning employee dismissals, transfers, etc. • Ensure that departmental disciplinary action is administered fairly and without regard to race, color, creed, national origin, age, sex, religion, handicap, or marital status. • Report occupational exposures to blood, body fluids, infectious materials, and hazardous chemicals in accordance with the facility's policies and procedures governing accidents and incidents. • Report known or suspected incidents of fraud to the Administrator. • Ensure that departmental computer workstations left unattended are properly logged off or the password protected automatic screen-saver activates within established facility policy guidelines. Nursing Care Functions • Inform nursing service personnel of new admissions, their expected time of arrival, room assignment, etc. • Ensure that rooms are ready for new admissions. • Greet newly admitted residents upon admission. Escort them to their rooms as necessary • Make rounds with physicians as necessary. • Encourage attending physicians to record and sign progress notes, physicians' orders, etc., on a timely basis and in accordance with current regulations. • Inform the Director when physician visits are not made in a timely manner. • Consult with the resident, his/her family, and the resident's physician in planning the resident's care, treatment, rehabilitation, etc., as necessary. • Notify the resident's attending physician and next-of-kin when there is a change in the resident's condition. • Visit residents on a daily basis in order to observe and evaluate each resident's physical and emotional status. • Ensure that direct nursing care be provided by a licensed nurse, a certified nursing assistant, and/or a nurse aide trainee qualified to perform the procedure. • Review nurses' notes to ensure that they are informative and descriptive of the nursing care being provided, that they reflect the resident's response to the care, and that such care is provided in accordance with the resident's wishes. • Provide direct nursing care as necessary. • Start IVs, obtain sputum, urine and other specimens for lab tests as ordered. • Take TPRs, blood pressures, etc., as necessary. • Admit, transfer and discharge residents as necessary. • Report problem areas to the Director. Assist in developing and implementing corrective action. • Keep the Director informed of the status of residents and other related matters through written/oral reports. • Assist the Charge Nurse in monitoring seriously ill residents. • Authorize the use of restraints when necessary and in accordance with our facilities policies and procedures. • Ensure that all RNs and LPNs on your shift comply with written procedures for the administration, storage, and control of medications and supplies. • Monitor medication passes and treatment schedules to ensure that medications are being administered as ordered and that treatments are provided as scheduled. • Review medication cards for completeness of information, accuracy in the transcription of physician orders, and adherence to stop order policies. • Inspect the nursing service treatment areas daily to ensure that they are maintained in a clean and safe manner. • Ensure that residents who are unable to call for help are checked frequently. • Meet with residents, and/or family members, as necessary. Report problems to the Director. • Assist in arranging transportation for discharged residents as necessary. • Inform family members of the death of the resident. • Call funeral homes when requested by the family. Staff Development • Participate in developing, planning, conducting, and scheduling in-service training classes that provide instructions on "how to do the job," and ensure a well-educated nursing service department. • Assist the In-service Director/Educator in developing annual facility in-service training programs (e.g., OSHA, TB, HIPAA, Abuse Prevention, Safety, Infection Control, etc.). • Assist the Director in planning clinical supervision for nurse aide trainees. • Attend and participate in continuing education programs designed to keep you abreast of changes in your profession, as well as to maintain your license on a current status. Safety and Sanitation • Assist the Safety Officer in developing safety standards for the nursing service department as necessary. • Assist the Director and/or Infection Control Coordinator in identifying, evaluating, and classifying routine and jobrelated functions to ensure that tasks in which there is potential exposure to blood/body fluids are properly identified and recorded. • Ensure that all personnel performing tasks that involve potential exposure to blood/body fluids participate in appropriate in-service training programs prior to performing such tasks. • Ensure that an adequate supply of personal protective equipment is on hand and readily available to personnel who perform procedures that involve exposure to blood or body fluids. • Ensure that personnel follow established procedures for the use and disposal of personal protective equipment. • Monitor your shift's personnel to ensure that they are following established safety regulations in the use of equipment and supplies. • Ensure that all nursing service personnel comply with established departmental policies and procedures. • Ensure that nursing service work areas (i.e., nurses' stations, medicine preparation rooms, etc.) are maintained in a clean and sanitary manner. • Ensure that all resident care rooms, treatment areas, etc., are maintained in a clean, safe, and sanitary manner. • Ensure that nursing service personnel follow established handwashing and hand hygiene procedures. • Ensure that nursing service personnel participate in and conduct all fire safety and disaster preparedness drills in a safe and professional manner. • Participate in the development, implementation, and maintenance of the infection control program for monitoring communicable and/or infectious diseases among the residents and personnel. • Ensure that nursing service personnel follow established infection control procedures when isolation precautions become necessary. • Participate in the development, implementation and maintenance of the procedures for reporting hazardous conditions or equipment. • Ensure that all personnel wear and/or use safety equipment and supplies (e.g., back brace, mechanical lifts, etc.) when lifting or moving residents. • Report missing/illegible labels and MSDSs to the safety officer or other designated person. Equipment and Supply Functions • Recommend to the Director the equipment and supply needs of the department. • Ensure that an adequate stock level of medications, medical supplies, equipment, etc., is maintained on premises at all times to meet the needs of the resident. • Assist the Maintenance Director in developing a preventive maintenance program for maintaining the nursing service department's equipment and supplies in a safe and operable manner. • Participate in the development and implementation of the procedures for the safe operation of all nursing service equipment. • Ensure that only trained and authorized personnel operate the nursing service department's equipment. • Ensure that all personnel operate nursing service equipment in a safe manner. • Monitor nursing procedures to ensure that nursing service supplies are used in an efficient manner to avoid waste. • Ensure that appropriate MSDSs are on file for hazardous chemicals used in the nursing service department. Care Plan and Assessment Functions • Participate in the development of written preliminary and comprehensive assessments of the nursing needs of each resident as necessary. • Participate in the development of a written plan of care (preliminary and comprehensive) for each resident that identifies the problems/needs of the resident, indicates the care to be given, goals to be accomplished, and which professional service is responsible for each element of care. • Encourage the resident to participate in the development and review of his/her care plan. • Review resident care plans for appropriate resident goals, problems, approaches, and revisions based on nursing needs. • Ensure that all personnel involved in providing care to the resident are aware of the resident's care plan. Ensure that nursing personnel refer to the resident's care plan prior to administering daily care to the resident. • Review nurses' notes to determine if the care plan is being followed. • Assist the Resident Assessment/Care Plan Coordinator in planning, scheduling, and revising the MDS, including the implementation of RAPs and Triggers. • Review resident's medical and nursing treatments to ensure that they are provided in accordance with the resident's care plan and wishes. Budget and Planning Functions • Keep abreast of economic conditions/situations, and recommend to the Director adjustments in nursing services that ensure the continued ability to provide quality care. • Recommend to the Director the equipment needs of the nursing service department. • Report suspected or known incidence of fraud relative to false billings, cost reports, kickbacks, etc. Supervisory Requirements Assist with the overall supervision of and management of the nursing staff. As RN, you are delegated the administrative authority, responsibility, and accountability necessary for carrying out your assigned duties. Qualification Education and/or Experience Must posess, as a minimum, a Nursing Degree an accredited college or university. Must have training in rehabilitative and restorative nursing practices. 2 years or more experience preferably in a long-term care facility. Language Skills Must be able to read, write, speak, and understand the English language. Ability to read technical procedures. Ability to read and comprehend policy and procedure manuals. Ability to effectively present information and respond to questions from managers and employees. Mathematical Skills Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. Reasoning Ability Must possess • the ability to make independent decisions when circumstances warrant such action with the ability to solve practical problems. • the ability to deal tactfully with personnel, residents, family members, visitors, government agencies/personnel, and the general public. • leadership and supervisory ability and the willingness to work harmoniously with and supervise other personnel. • the ability to plan, organize, develop, implement, and interpret the programs, goals, objectives, policies and procedures, etc., that are necessary for providing quality care. Must demonstrate the knowledge and skills necessary to provide care appropriate to the age-related needs of the residents served. Be a supportive team member, contribute to and be an example of team work and team concept. Must be knowledgeable of nursing and medical practices and procedures, as well as laws, regulations, and guidelines that pertain to nursing care facilities. Must have patience, tact, a cheerful disposition and enthusiasm, as well as the willingness to handle difficult residents. Must be willing to seek out new methods and principles and be willing to incorporate them into existing nursing practices. Must be able to relate information concerning a resident's condition. Must not pose a direct threat to the health or safety of other individuals in the workplace. Certificates, Licenses, Registrations Must posess a current, unencumbered, active license to practice as an RN in this state. Current CPR certification. Knowledge and experience with PCC preferred. Must maintain all required continuing education/licensing. Must remain in good standing with the State Board of Nursing at all times. Physical Demands Must be able to move intermittently throughout the workday. Must be able to speak and write the English language in an understandable manner. Must be able to cope with the mental and emotional stress of the position. Must be able to see and hear or use prosthetics that will enable these senses to function adequately to ensure that the requirements of this position can be fully met. Must function independently, and have flexibility, personal integrity, and the ability to work effectively with residents, personnel, and support agencies. Must meet the general health requirements set forth by the policies of this facility, which include a medical and physical examination. Must be able to relate to and work with the ill, disabled, elderly, emotionally upset, and, at times, hostile people within the facility. Must be able to push, pull, move, and/or lift a minimum of 25 pounds to a minimum height of 5 feet and be able to push, pull, move, and/or carry such weight a minimum distance of 50 feet. May be necessary to assist in the evacuation of residents during emergency situations. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Works in office area(s) as well as throughout the nursing service area (i.e., drug rooms, nurses' stations, resident rooms, etc.). Moves intermittently during working hours. Is subject to frequent interruptions. Is involved with residents, personnel, visitors, government agencies/personnel, etc., under all conditions and circumstances. Is subject to hostile and emotionally upset residents, family members, personnel, and visitors. Communicates with the medical staff, nursing personnel, and other department directors. Works beyond normal working hours and on weekends and holidays when necessary. Is subject to call back during emergency conditions (e.g., severe weather, evacuation, post-disaster, etc.). Is involved in community/civic health matters/projects as appropriate. Attends and participates in continuing educational programs. Is subject to injury from falls, burns from equipment, odors, etc., throughout the workday, as well as reactions from dust, disinfectants, tobacco smoke, and other air contaminants. Is subject to exposure to infectious waste, diseases, conditions, etc., including TB and the AIDS and Hepatitis B viruses. May be subject to the handling of and exposure to hazardous chemicals. Maintains a liaison with the residents, their families, support departments, etc., to adequately plan for the residents' needs. Additional Information Note: Nothing in this job specification restricts management's right to assign or reassign duties and responsibilities to this job at any time. Critical features of this job are described under various headings above. They may be subject to change at any time due to reasonable accommodation or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are not intended to be construed as a complete list of all responsibilities, duties, and skills required of employees in this position.
Program Manager, Brand and Creative
Horizontal Talent, Sunnyvale
Job Description: The Brand and Creative Team consists of a multi-disciplinary team of experts in Strategy, Brand, Creative, Media Production, Web, and Creative Operations. The Creative Operations function within Brand and Creative focuses on project and account management, and optimizing processes, tools, and talent. We are an evolving function within a dynamic organization, and this role's work will have a direct link to the group's transformation toward its goals. We are seeking an experienced and dynamic Program Manager to drive delivery of cross- functional projects across various types of marketing deliverables. The Project/Program Management team serves as a key driver of creative, social, content, media, and web projects and programs. In this role, you'll have the opportunity to collaboratively deliver work that advances the business and elevates our brand, fusing deep project management skills with expertise in marketing and creative. As a member of the Operations team, you'll also have the opportunity to actively participate in shaping and rolling out large scale process initiatives, optimizations and improvements to our tools and workflows. Responsibilities: Lead project execution by developing comprehensive project and resource plans, driving work forward in a collaborative team environment, and bringing clarity of R&Rs and briefs to project teams Ensure that progress aligns with expected guidelines, adheres to timelines and maintains high quality Proactively manage project obstacles, identify and mitigate risks and issues, and pivot quickly as needed Cultivate a collaborative and productive work environment and set a solutions-oriented tone for project teams Maintain transparent communication with project teams, leadership and stakeholders Maintain precise project documentation and data integrity for reporting, and look for ways to amplify our value to the business using data Conduct post-project evaluations to assess success, learn lessons, and recommend future improvements Seek opportunities to enhance productivity through process improvements, automation, and technology Collaborate with internal customers and Account Managers to identify and coordinate new project requirements and develop project scope Develop resourcing strategies and plans, in partnership with people managers, to optimize talent Bring expertise in the creative process to driving outstanding results in delivery Understand the customer journey and contribute input and suggestions for campaign strategies. Be knowledgeable about stakeholders' business, key issues, competitive situation, industry trends, and the projects assigned to the B&C team as well as other communication partners Required Skills and Experience Experience in global brands, in-house, or agency roles within creative, marketing, or integrated communications teams, managing projects across marketing deliverables BA/BS degree preferred, PMP or another Project Management Certification welcome Solid, demonstrated (5+ years) track record of progression in Project and Program Management Highly proficient in project management systems, including Workfront and Jira, with experience resourcing teams and maintaining data and reporting Ability to think creatively and strategically, identify and resolve problems while juggling multiple projects. Excellent self-management skills. Ability to lead and thrive in dynamic environments, passionate about driving success through positive relationships and operational excellence Superior scope/budget stewardship, time management, organization, and prioritization skills Proven ability to work in a robust and agile environment, while consistently paying attention to accuracy and quality of work Measurable experience managing creative workflows across print, video, digital, and experiential tactics. Exceptional communication skills, able to convey high-level concepts and business direction Strong problem-solving skills and the ability to navigate ambiguity Experience collaborating with Legal, Regulatory, and Clinical departments to develop content Required Education and Training 5+ years of progressive project/program management experience in an in-house creative group, creative agency, or similar environment Horizontal facilitates valuable and productive conversations between you and potential employers. We can assist you in growing your career by partnering you with employers that offer challenging assignments. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $65 - $73 per hour. This is not a guarantee of compensation, as final offer amount may vary based on factors including but not limited to experience and geographic location.
Senior Human Factors Engineer
Intuitive Surgical, Inc., Sunnyvale
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description Primary Function of PositionThe Senior Human Factors Engineer collaborates with various teams to develop new products that are practical, profitable, and appealing.As part of product-development teams, the Senior Human Factors Engineer plays a key role in user-centered design research. They examine use-related risks, conduct usability testing, and track design iterations. Responsibilities include evaluating product designs with end-users, conducting qualitative research, and developing tools to measure UX.Roles and Responsibilities:Research:Collect detailed insights on user interactions with Intuitive products using interviews, simulations, observations, and task analyses.Support project-based and advanced longitudinal-research regarding cognitive/behavioral and ergonomic human factors topics.- Complete research studies: design, develop instruments, collect data (desktop & field), review data, report findings, and communicate with partners.Create actionable insights for improving products and services based on results of internally and externally inspired research.Study usability factors: physical, cognitive, social, organizational aspects that affect interaction with Intuitive products.Draft usability requirements.Design:Contribute to workflow and user interface designs and negotiate design recommendations to mitigate use errors and improve usability.Develop usability requirements driving user interface design, training, and labeling.Assist creation and revision of user-interface requirements documents.Highly advocate for clinical caregiver experience safety and usability. Consider both user/customer and business needs.Collaborate:Manage the efforts required to create and update usability risk analyses for Intuitive Surgical products.Represent the Human Factors function on core teams for large projects.Coordinate human factors efforts across projects involving several sub-systems.Manage usability-engineering activities within development projects and provide schedules and status to technical product managers and engineering project managers.Teach junior engineers and colleagues usability engineering methods. Mentor in intuitive product development processes within the organization.Track usability findings from the field and support responses to field actions. Qualifications Required Skills and ExperienceThis position requires experience leading research with diverse populations, especially in Health Care, shown through a portfolio.Ability to evaluate products rapidly using different techniques in various environments, such as prototype and usability testing in the lab. This includes evaluating services, products, and tools outside the lab.Great skills in writing, speaking, and presenting in a professional setting, using various communication methods like email and video.I can work with different departments and levels of management like marketing and regulatory to solve usability issues.Ability to change elevations quickly as well as an appetite for fuzzy front-end development.Ability to travel internationally, as well as domestically (up to 25%).Required Education and TrainingMinimum Education: Bachelor's degree in Human Factors Engineering, Cognitive Psychology, Computer Science with HCI focus, or related field. Master's degree is highly recommended.Minimum of 8 years related experience with a bachelor's degree in engineering required. Six years with a master's is also acceptable. An alternative is a relevant PhD with 3 years of experience. Another option is equivalent experience with human factors or biomedical devices.Experience in medical device or similar highly regulated industry is of significant value.Preferred Skills and ExperienceExperience with data collection tools, e.g., Qualtrics.Ability to parse large amounts of data using QDA and statistical software like NVivo, atlas.ti, SPSS, SAS, Stata, R. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Base Salary Range Region 1: $159,900 USD - $230,100 USD Base Salary Range Region 2: $136,000 USD - $195,600 USD Shift: Day Travel: 25% of the time Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
Senior Human Factors Engineer
Intuitive Surgical, Inc., Sunnyvale
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description Primary Function of Position:The Sr. Human Factors Engineer on the Intuitive Human Factors team collaborates with various teams to develop new products. They guide the development to ensure feasibility, viability, and desirability.The Sr Human Factors Engineer is a key member in product development teams, leading user-centered design research. They **study** use-related risks, conduct usability testing before launch, track designs in the field, evaluate product designs, conduct qualitative research, **examine** usability considerations, and develop tools for UX measurement.Essential Job Duties:Research:Gather insights on user interactions with Intuitive products using interviews, simulations, observations, and task analyses.Support project-based and advanced longitudinal-research regarding cognitive/behavioral and ergonomic human factors topics.- Conduct research studies from design to reporting, including instrument development, data collection, scrutiny, and communication with partners.Create actionable insights for improving products and services based on results of internally and externally inspired research.Study usability factors like physical, cognitive, social, and organizational aspects affecting performance with Intuitive products.Draft usability requirements.Design:Contribute to workflow and user interface designs and negotiate design recommendations to mitigate use errors and improve usability.Develop usability requirements driving user interface design, training, and labeling.Assist creation and revision of user-interface requirements documents.Consistently advocate for clinical caregiver experience, balancing user needs with business needs, focusing on safety and usability.Collaborate:Manage the efforts required to create and update usability risk analyses for Intuitive Surgical products.Represent the Human Factors function on core teams for large projects.Coordinate human factors efforts across projects involving several sub-systems.Manage usability-engineering activities within development projects and provide schedules and status to technical product managers and engineering project managers.Train junior engineers in usability methods. Teach intuitive product development practices to team members and interns.Track usability findings from the field and support responses to field actions. Qualifications Required Skills and ExperienceAbility to conduct user research in diverse populations shown through a portfolio of designing and executing studies (preferably in Health Care).Ability to test products quickly in lab or field, including prototype, usability, and feasibility testing. Experimental services may also be evaluated.Good writing and speaking skills in a professional environment using various communication methods like email and video conferencing.- Able to collaborate with different groups and levels of management within the organization. - Work with engineering, marketing, clinical engineering, and regulatory to solve complex usability issues.Ability to change elevations quickly as well as an appetite for fuzzy front-end development.Ability to travel internationally, as well as domestically (up to 25%).Required Education and TrainingMinimum education requirement is a BS in Human Factors Engineering, Cognitive Psychology, Computer Science with HCI focus, or related field. An MS degree is highly preferred.At least 8 years experience with engineering degree, 6 years with master's, 3 years with PhD, or equivalent.Experience in medical device or similar highly regulated industry is of significant value.Preferred Skills and ExperienceExperience with data collection tools, e.g., Qualtrics.Ability to examine large amounts of data using QDA software like NVivo, atlas.ti and statistical software like SPSS. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Base Salary Range Region 1: $159,900 USD - $230,100 USD Base Salary Range Region 2: $136,000 USD - $195,600 USD Shift: Day Travel: 25% of the time Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
Manager Vision RD Engineering
Intuitive Surgical, Inc., Sunnyvale
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description Primary Function of PositionThe Manager of Vision R&D Engineering will be responsible for leading a team of engineers who design innovative endoscope architectures to enable superior surgical vision. This role is a key part of early evaluation stages of the vision hardware product pipeline. The role will be leading cross functional teams for development of new products.Essential Job Duties This key technical management role will guide and mentor a talented R&D engineering organization responsible developing the next generation of electro-opto-mechanical product designs. The leadership requires the ability to collaborate across functions to clarify the customer need, brainstorm engineering approaches, and select winning concepts that balance performance, program risk, and commercial viability. The leader will have a track record of effectively working closely with the electrical, optical, and other mechanical teams to collaboratively develop these novel designs.Build and mentor a strong team of self-directed engineers. Encourage an ambitious, exploratory, creative mindset in the teamIdentify, isolate, and plan to resolve high-risk questions that stand between today and confidence that we can meet the customer needs with technological solutions. In other words, find the science projects and reduce their risk until they become engineering implementation tasksWork with Multiport Vision PMO to deliver risk-reduced concepts to the next engineering team in the product development flowCollaborate across the organization to assure that proposed designs meet the needs of all customers : manufacturing, quality assurance, regulatory, human factors, clinical, supply chain Qualifications Required Skills and Experience Track record of leading and developing sustainable teamsAbility to effectively collaborate with a team that is split among geographic regions, organize effective collaboration in time zones with limited work-day overlap, and balance cultural differences among contributorsDemonstrated ability to mentor contributors on processes, implement processes for product safety and quality, and drive product and process improvements that lead to improving patient outcomes, surgeon experience, and business performanceDemonstrated ability to distill the requirements into clear goals and actions for the team that deliver improved products for our customers in a timely mannerRequired Education and Training Minimum B.S. degree in Engineering discipline, M.S. preferred.A minimum 1-3 years' experience managing an engineering team.A minimum 8-10 years' experience in design, manufacturing, or service environment for complex electro-mechanical products.Preferred Skills and ExperiencePrior experience in medical device design and manufacturingExcellent organizational skills; Able to manage multiple fast-paced projectsPrior experience with Agile Change Control and SAPExperience in an ISO 13485, ISO 9001, or medical device manufacturing environment Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Base Salary Range Region 1: $165,600 USD - $238,400 USD Base Salary Range Region 2: $140,800 USD - $202,600 USD Shift: Day Travel: 10% of the time Workplace Type: Onsite - This job is fully onsite.