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Human Factors Engineer Salary in USA

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Human Factors / Usability Engineering
American Cybersystems, Inc., New Haven
Innova Solutions is immediately hiring for a Human Factors / Usability Engineering. Position : Type: Full Time, Contract Duration : 6+ Months Location: New Heaven, CT or Boston, MA As a Human Factors / Usability Engineering, your responsibilities:: Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-market. Member of device development team responsible for determining the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products. Lead user related risk analysis for the programs under development. Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging) Educate team members and other internal stakeholders on the Human Factors development process and approach Interface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking. Communicate effectively, both verbally and in writing, internally across departments and with external suppliers. Ensure all human factors engineering comply with the Companys quality assurance requirements as well as applicable regulatory requirements. You will need to have: Experience in commercialization of medical device and/or combination products. Deep knowledge of regulatory and compliance requirements for device risk management and human factors/usability engineering for combination product. Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch and life cycle management. Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms. Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations. Deep knowledge of human factor/usability engineering, safety, performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements, and related FDA HF guidance). [For office-based positions:]. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Bachelor's in engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 years' experience or Masters / Doctorate in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 8-to-10-year experience in medical device development in Ergonomics and Human Experience with injector based combination product preferred Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you! Obulesu Arikotam [email protected] (+1) 713-636-5937 PAY RANGE AND BENEFITS: Pay Range*: Between $53 to $55 Per Hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
Human Factors & Ergonomics Engineer, Amazon Robotics
Amazon, North Reading, MA, US
DESCRIPTIONAre you inspired by invention? Is problem solving through teamwork in your DNA? Do you like the idea of seeing how your work impacts the bigger picture? Answer yes to any of these and you’ll fit right in here at Amazon Robotics. We are a smart team of doers that work passionately to apply cutting edge advances in robotics and software to solve real-world challenges that will transform our customers’ experiences in ways we can’t even imagine yet. We invent new improvements every day. We are Amazon Robotics and we will give you the tools and support you need to invent with us in ways that are rewarding, fulfilling and fun.The Human Factors and Ergonomics team at Amazon Robotics works to ensure the safety and productivity of Amazon associates around the world. We ensure that AR products are designed to fit the needs of our associates by proactively assessing every design from inception against human centric design requirements. We evaluate conceptual designs using digital simulations, iteratively test prototypes using advanced wearable technology, and validate products at beta release to the field. Key job responsibilitiesWe are looking for a bright and motivated HFE engineer who is excited to work on complex, real-world challenges. We are interested in someone who has experience with human factors and ergonomics analysis tools, methods, and thresholds. We are seeking a candidate with research experience, who is interested in and comfortable working with complex data. The responsibilities of this role include:- Collaborating with design engineering to evaluate work processes and workspaces that adhere to human factors and ergonomics standards- Supporting the execution of comprehensive assessments of workstations and processes covering biomechanical, physiological, and psychophysical demands- Effectively communicating results and associated design rationale to multiple engineering and operations entities- Supporting human factors and ergonomics research projects, including study execution, data collection, and analysis- Continuously striving to gain in-depth knowledge of your profession, as well as branch out to learn about intersecting fields, such as user experience, industrial design, and systems engineering- Traveling to either of the two Boston sites (BOS12 or BOS27) to conduct assessments and research activities, up to 25% of the timeA day in the lifeAmazon offers a full range of benefits that support you and eligible family members, including domestic partners and their children. Benefits can vary by location, the number of regularly scheduled hours you work, length of employment, and job status such as seasonal or temporary employment. The benefits that generally apply to regular, full-time employees include: 1. Medical, Dental, and Vision Coverage 2. Maternity and Parental Leave Options 3. Paid Time Off (PTO) 4. 401(k) Plan If you are not sure that every qualification on the list above describes you exactly, we'd still love to hear from you! At Amazon, we value people with unique backgrounds, experiences, and skillsets. If you’re passionate about this role and want to make an impact on a global scale, please apply!About the teamAt Amazon Robotics, we create high tech products that help associates to work faster, safer, and with greater satisfaction. In order to best serve our associate customers, we need to incorporate ergonomic considerations into the design cycle for associate facing hardware development projects. Our team conducts human factors and ergonomic evaluations early and often, in order to minimize injury potential and enhance the overall associate experience.We are open to hiring candidates to work out of one of the following locations:Detroit, MI, USA | North Reading, MA, USA | Westborough, MA, USABASIC QUALIFICATIONS- Bachelor's degree in Human Factors, Ergonomics, Biomedical Engineering, Industrial Engineering, Mechanical Engineering, or Life Sciences (e.g. Biology, Physiology, Kinesiology, Biomechanics)- Experience conducting human factors/ergonomics assessments, using tools such as: NIOSH Lifting Equation (LI, CLI, VLI), Liberty Mutual MMH Tables, Duty Cycle Equation, RCRA, Revised Strain Index, OCRA, 3DSSPP, EEPP, Siemens Jack/Process Simulate, etc.- Experience with motion capture analysis (e.g., Xsens IMU or optical systems)- Strong written and verbal communication skills- Skilled using Excel (or more advanced tools such as MATLAB or Python) for data manipulation and analysisPREFERRED QUALIFICATIONS- Experience conducting laboratory studies in human performance using motion capture technology, electromyography, metabolic carts, etc.- Ability to perform independent biomedical signal processing and statistical analysis of large databases using your own code in MATLAB or Python- Leveraging of advanced statistical methods, such as principal component analysis, support vector machines, neural networks, etc. to gain insight of human capacity and variabilityAmazon 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.
Team Leader Human Factors Design Engineer (Web/Mobile Design)
Garmin International, Olathe
OverviewWe are seeking a full-time Team Leader Human Factors Design Engineer (Web/Mobile) in our Olathe, KS location. In this role, you will be responsible for directing and coordinating activities of a Human Factors Design Engineering team responsible for the development and design of multiple, highly complex aviation products and services. Essential FunctionsCoordinate associates, methods, and tools to develop project road maps, estimates, budgets, and deliverables in alignment with Gamin Aviation business goalsPerform administrative duties related to associate performance management, annual team budgets, and process improvementLead a team of Human Factors Design Engineers with diverse capability levels in the definition/documentation of technical product roadmaps involving pilot interfaces, defining new features including coordination of stakeholder input, technical research, competitive analysis, writing system design/description documentation and creating associate software change requestsPromote/lead efforts to ensure consistency using Garmin aviation user interface guidelines, user interface reviews, providing UI training to software engineers and soliciting feedback to improve guidelines as neededLead/coordinate concept development, product design and development activitiesLead/coordinate concepts for complex products and product families including identification of market need, technical and market feasibility analysis, system design and product definitionDirectly supervise Human Factors team members with daily observation, assuring appropriate attendance and providing assistance to team membersEnsure team meets overall goals in accordance with the product development plan or market requirements and ensure project milestones are metDirectly supervise various levels of team members by setting the tone for a healthy team environment and providing individualized coaching, training and mentoringParticipate in recruiting activities, interview, hire, train, and evaluate performance for the team which includes performance evaluations/associate relations with HRBasic QualificationsBachelor's Degree in Computer Science, Electrical Engineering, Mechanical Engineering, Computer Engineering, Aerospace Engineering, Human Factors, Aviation, Math or Physics AND a minimum of 5 years experience in a technical role, performing duties similar to the functions of this team OR a minimum of 10 years relevant work experienceExcellent academics (cumulative GPA greater than or equal to 3.0)Demonstrates advanced working knowledge of aviation, avionics, and industry standards, guidance material, and regulationsDemonstrates expert level knowledge of Garmin Integrated Flight Decks and advanced proficient knowledge of all Garmin aviation productsDemonstrates proficient knowledge of aviation industry and competitionStrong working knowledge of aviation human factors and associated guidance and regulatory materialDemonstrated strong and effective verbal, written, and interpersonal communication skillsMust be team-oriented, possess a positive attitude, work well with others, and be a driven problem solver with proven success in solving difficult problemsBroad technical knowledge and skills in one or more areas of avionics systems and product developmentDesired QualificationsMaster's Degree in Human Factors, Human Computer Interaction, or other relevant fieldDemonstrated advanced knowledge of aviation human factors and associated guidance and applicable FAA and international regulatory materialProficient using common rapid prototyping tools, remote research tools (ex. Figma, UserZoom, Qualtrics, etc.) and/or data analysis tools (statistics in Minitab, Python, SAS, SPSS, etc.)Pilot's certificate with Instrument RatingGarmin International is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran's status, age or disability.This position is eligible for Garmin's benefit program. Details can be found here: Garmin Benefits
Senior Human Factors Researcher
Garmin International, Olathe
OverviewWe are seeking a full-time Senior Human Factors Researcher in our Olathe, KS location. In this role, you will be responsible for leading the development and design of complex aviation products and services and ensuring that systems are designed to meet the needs and capabilities of the intended users. Essential FunctionsDesign interfaces, controls, displays, and user experiences that are intuitive and optimize human performance and minimize human errorUse variety of advanced methods to develop project road maps, milestones, staffing estimates, and budgets that align with Gamin Aviation business goalsLead research and proactively identify possible Human Factors issues in the design of new features and productsApply human-centered design techniques to develop insights and generate new product ideasEmploy innovative methods to communicate research and design requirementsEffectively articulate and defend design decisions and recommendationsCreate design standards/procedures to ensure consistent user interface designs and behaviors across aviation products/servicesCoordinate research planning and preparation including recruiting, scheduling, and test script developmentEmploy both qualitative/quantitative research methods to answer research questionsModerate, observe, and take detailed notes during usability testing sessionsSynthesize results from multiple research projects across aviation to identify systemic issues and opportunities to improve products/servicesPresent research results and design recommendations to support stakeholder decision-makingWork collaboratively/professionally with cross-functional teams of product designers and business stakeholdersProactively initiate communication with leadership to understand vision and strategy and communicate to the product teamApply advanced knowledge of Human Factors in aviation and avionics, as well as related industry standards, guidance material, and regulationsLead initiatives to develop or improve Human Factors design processesLead as a recognized expert within the organization in Human Factors design and researchAdhere to ethical research standardsCommunicate status of work clearly by thoroughly documenting work in an organized mannerRemain current on research/design trends, methods, techniques, and softwareMentor and/or provide training to less-experienced Human Factors Design team members and internsApply Garmin's Mission, Vision, Values, and Quality Policy and enthusiastically exhibit a desire to see Garmin succeedAssist in general aviation advocacy through training and outreach activities in Garmin's flight simulator labsLead workshops including design sprints and service blueprintingRepresent Human Factors in software Change Control Board (CCB) meetingsBasic QualificationsBachelor's Degree or above in Human Factors, Human Computer Interaction, User Experience, Human Centered Design, Aviation, or related field AND a minimum of 5 years relevant experience OR an equivalent combination of education and relevant experienceExcellent academics (cumulative GPA greater than or equal to 3.0 as a general rule) with the demonstrated ability to apply learned knowledgeDemonstrated experience with quantitative/qualitative methodologies such as usability testing, task analysis, heuristic evaluations, contextual inquiries, and surveysDemonstrated experience analyzing and synthesizing user data to identify usability insights and translate those insights into actionable recommendationsDemonstrated proficiency with rapid digital prototyping tools like Figma or PhotoshopDemonstrated strong and effective verbal, written, and interpersonal communication skillsDemonstrated experience applying usability, accessibility, and other industry standard practicesDemonstrated leadership in coordinating multiple projects of varying complexityMust be team/detail oriented, possess a positive attitude, demonstrate ability to work well with others in a highly collaborative environment, and can work proactively/effectively with little supervisionAble to lift up to 25lbs using safe lifting techniquesDesired QualificationsOutstanding academics (cumulative GPA greater than or equal to 3.5) with the demonstrated ability to apply learned knowledgeDemonstrates strong working knowledge of Garmin Integrated Flight Decks and general knowledge of all Garmin aviation products and competitor productsDemonstrates strong working knowledge of aviation human factors and associated guidance and applicable FAA and international regulatory materialProficient using common rapid prototyping tools, remote research tools (ex. Figma, UserZoom, Qualtrics, etc.) and/or data analysis tools (statistics in Minitab, Python, SAS, SPSS, etc.)Pilot's Certificate with an Instrument RatingGarmin International is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran's status, age or disability.This position is eligible for Garmin's benefit program. Details can be found here: Garmin Benefits
Process Safety/ Human Factors Engineer - Junior Level/Intern
Wood PLC, Houston
JOB DESCRIPTION Wood is currently searching for a Process Safety / Human Factors Engineer - Junior Level / Intern to participate on projects out of the Wood Houston - Park Ten campus. Project scope may vary, but will primarily focus on providing input to studies and tools pertaining to Process Hazards Analysis (PHA) and Risk Management, as well as contributing to the preparation of Human Factors deliverables on projects. Authorization to work lawfully in the US without sponsorship from Wood is requiredRESPONSIBILITIES Uses advanced technical knowledge to contribute to technical safety study work with guidance and direction from more senior staff. Expected to participate on individual PHA and Risk Management studies on projects ranging from smaller scale to large and complex projects, in addition to evaluating engineering tools in use on such. Comprehensive understanding of frequency analysis / computational analysis related to desktop assessments such as Fire and Explosion Risk Assessments. Basic understanding of Quantitative Risk Assessment (QRA) and Formal Safety Assessment studies. Participate in human factors support on projects with guidance and direction from more senior staff. Participate in the development of project deliverables, including and related to: human factors checklists, valve and instrumentation criticality analysis, and human factors package reviews. Strong communication and interface skills between the technical safety team and other engineering disciplines. QUALIFICATIONS Bachelor's Degree in Chemical Engineering, Mathematics, or similar from an accredited college or university (internships: ongoing education acceptable) Programing / operating experience using software related to risk-based approaches Ability to communicate both orally and in writing Occasional field visits, climbing stairs, ladders and lifting up to 25 lbs.
Senior Engineer II, Human Factors, Device Development
AstraZeneca, New Haven
**Hybrid means onsite 3 days per week**This is what you will do:This position will serve the role of Sr Engineer II for Human Factors of Alexion combination products within Global Product Development function of Alexion. The candidate will participate in the Human Factors / Usability Engineering for pipeline combination products as well as lifecycle management. This position will manage the human factors deliverables, overall user interface evaluation, study design, development of labeling, integration of user needs, use risk analysis and HF vendor selection. This role will interact with multiple functional teams including Clinical, Global Drug Safety, Marketing, Quality, and Regulatory, from clinical development through registration and commercial support.You will be responsible for:Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-marketMember of device development team responsible for determining the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.Lead user related risk analysis for the programs under development.Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)Educate team members and other internal stakeholders on the Human Factors development process and approachInterface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking.Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.Ensure all human factors engineering comply with the Company's quality assurance requirements as well as applicable regulatory requirements.You will need to have:Experience in commercialization of medical device and/or combination products. Deep knowledge of regulatory and compliance requirements for device risk management and human factors/usability engineering for combination product. Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch and life cycle management. Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms. Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations. Deep knowledge of human factor/usability engineering, safety, performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements, and related FDA HF guidance). As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have:Bachelor's in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 year's experience or Master's / Doctorate in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 8 to 10 year experience in medical device development in Ergonomics and Human Experience with injector based combination product preferredWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.#LI-EB1#LI-HYBRIDAstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Senior Controls Engineer
Amazon, Bellevue, WA, US
DESCRIPTIONAmazon created one of the most sophisticated supply chains in the world. From the introduction of Amazon Prime, to the use of advanced technology for package delivery; Amazon consistently drives change from the front of the pack.Amazon is seeking a Senior Controls Engineer to support the Amazon Logistics North America (AMZL NA) Material Handling Equipment (MHE) engineering team. This individual will challenge current processes, equipment, procedures, and electrical/controls specifications in our delivery stations, in order to come up with creative and implementable process improvement initiatives. This Senior Controls Engineer will also design development of new and existing Delivery station electrical and controls layouts. This position will be responsible for designing, managing and executing the next generation of delivery station processes, equipment, and operations. This is a unique opportunity to own new innovative projects that will advance the intelligence of our last mile business. Key job responsibilities- Own the design and development of industrial controls design for complex material handling systems considering human/equipment interactions for the Amazon Logistics North America network- Act as the interface between the MHE vendors and internal engineering design teams during the electrical and controls design of the complex material handling systems to ensure vendor compliance with Amazon controls specifications, and other applicable codes- Manage multiple high-visibility projects and tasks while effectively influencing, negotiating, and communicating with internal and external business partners, contractors and vendors- Conduct post mortem on designs after implementation in partnering with Safety, Maintenance, and Operations- Review new, advanced technology being introduced into the MHE systems with a focus on the electrical and controls interfacing requirements- Evaluate pricing of project proposals, change orders, and other quotes as they related to the electrical and controls scope- Use of AutoCAD, AutoCAD electrical, and/or Eplan for review of electrical schematics and layouts- Review and update of Amazon specifications to maintain the optimal technology in controls for Amazon Logistics- Understand material handling control systems, including relay logic, Allen Bradley PLCs, IPCs and industrial networks such as Ethernet, motor control systems and electrical distribution systems- Develop, document and update design standards in conjunction with worldwide design teams, with emphasis on the electrical and controls design standards- Experience with technical solutions that encompass advanced technology applications, conveyor hardware selection, material handling integration, and vendor commissioning content and expectations We are open to hiring candidates to work out of one of the following locations:Bellevue, WA, USABASIC QUALIFICATIONS- Bachelor's degree in Electrical Engineering, Engineering Technology, or other related Engineering - 5 years of experience in Electrical/Control systems, controls design, development, implementation in an industrial, logistics, production, or manufacturing environment- 5+ years of experience directly managing and responsible for multiple large projects PREFERRED QUALIFICATIONS- Master’s degree in Electrical or Controls Systems Engineering, or a related Sortation Technology Equipment Management (STEM) field- Operations Management/Distribution Center experience - Experience in technical leadership for large-scale industrial engineering projects or programs- Knowledge to communicate to vendors and make decisions using industry standard knowledge (Controls theory, mechanical/electrical systems, and passive infrastructure).- Knowledge of codesys, IPC technologies and Ethernet networks- Experience with complex automated material handling equipment, packaging technologies, and systems and high-speed manufacturing- Experience to build relationships with business partners and key stakeholders and the experience to work in a cross-functional organization- Written, verbal and interpersonal skills- Analytical and project management skills - PLC code development and software deployment experience- Knowledge to work independently in a fast-paced and rapidly changing environment- Knowledge with Functional Safety standards - Knowledge with Microsoft Office products: Excel, Project and OutlookAmazon 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 $93,200/year in our lowest geographic market up to $176,700/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. This position will remain posted until filled. Applicants should apply via our internal or external career site.
Engineer, Combination Products & Devices
AstraZeneca, Gaithersburg
Join us as a Device Engineer within our Global Technical Operations team! You will be part of the team accountable for commercial device technologies and combination products, maintaining the Design History File throughout the product life-cycle for commercial devices and combination products.This position is a corporate global role supporting multiple manufacturing sites, working closely with the combination product team members, device development group, and manufacturing sites to ensure smooth and seamless design transfer for combination product pipeline projects and life-cycle management of commercial combination products.What you will do:Engage in design control activities with the development team and manufacturing sites for new combination product introduction.Support Device Responsible Persons (DRPs) for Design History File (DHF) management through the life cycle including changes to on-market products. Complete risk management activities for the on-market combination products including maintenance of Risk Management Documents (e.g. FMEAs), and conduct periodic risk reviews based on ISO 14971. Minimum Qualifications:Bachelor's degree in Mechanical, chemical, or biomedical engineering or related engineering/scientific field with less than 1 year of industrial experience.Understanding OR knowledge of combination product, device development, and characterization including assembly processes, human factors, design controls, risk management, and organizational change.Procedures and compliance with Good Manufacturing Practices (GMPs) and Safety, Health, and Environment requirements knowledge.Preferred Qualifications: Knowledge of development and life-cycle management of injectable combination products.Experience supporting on-market biological combination products is a plus.Knowledge of statistics like control charting, capability analysis, Lean Six Sigma, and other problem-solving techniques.Experience with basic (e.g. Word, Excel, and PowerPoint) and drawing (e.g. Solidworks) software.Broad understanding of biopharmaceutical development from late-stage development through commercial life-cycle management.At AstraZeneca, we are passionate about new products and launches. We work with innovative and scientific products on our groundbreaking end-to-end supply chain, using the latest technologies and modern facilities. We are active players in growth and evolution. It's a clear long-term strategy, and we see our role. There's an excellent opportunity to influence how we develop supply chains, promoting a Lean attitude and leading on sustainability.Are you ready to accept constant challenges? For us, they are intellectually stimulating opportunities to learn more. A chance to come back stronger and eager for more. We keep pushing the boundaries as we work on implementing the best systems with cutting-edge science and manufacturing.Apply now to be part of our Operations team!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
Senior Human Factors Engineer
AstraZeneca, Waltham
Senior Human Factors EngineerDo you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.Summary of the group:The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems. The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.Main Duties & Responsibilities:The candidate will be responsible for the following activities:Developing HFE strategies and leading/supporting HF activities on drug delivery device technology development and/or drug-device combination product program teams from early-stage development to new product introduction and support for on-market products. This includes ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.Authoring HF deliverables for device design history files. Writing HF sections for health authority submissions and written responses.Interacting with other HF group members and senior leaders with regards to HF strategy and implementation.Improving internal HFE processes at AstraZeneca to ensure consistency, compliance and efficiencyEducation & Experience Requirements:Education: Bachelor's or Master's Degree in human factors engineering, bioengineering, mechanical engineering, or related fieldExperience:Bachelor's Degree and 10+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development -OR- Master's Degree and 8+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development.Required Skills:Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combination products and how to integrate into end-to-end combination product developmentDesigning, planning, and implementing ethnographic, formative, or summative usability studies, with or without the support of external consultanciesDemonstrated ability to translate multiple inputs (e.g., study results, technical constraints, etc.) into user needs and/or design recommendationsProven ability to collaborate actively and proactively with others cross-functionally, particularly to champion initiatives or establish processes, with strong interpersonal skills High level of initiative and ability to work independentlyAbility to analyze data, including knowledge and proficiency with basic statisticsDesired Skills:Ability to communicate effectively in writing, verbally, and as a presenterDemonstrated time management, critical thinking, decision-making, and organization skillsComplex problem-solving, root cause investigation, and technical development methodologiesExperience with development of promotional instructional materials and patient support programs for new product introductions and on-market product support based on understanding of the patient journey and passion to improve the experience with our productsWorking knowledge of periodic risk review and change control processes for on-market drug-device combination productsAbility to adapt to a rapidly changing environmentWhy AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a biopharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
Associate Director (Human Factors Engineering)
AstraZeneca, Waltham
Associate Director (Human Factors Engineering)Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.Summary of the group:The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems. The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.About the role:The successful candidate will be a strong voice of user/patient centricity across AstraZeneca. This candidate will be a leader in the human factors engineering group. They will build strong relationships and collaborate with cross-functional leaders in development, regulatory, quality, clinical, commercial, and operations, to guide development of combination products and ensure these products are safe and effective for use. Main Duties & Responsibilities:Proactive management of human factors engineering work across pipeline projects. Anticipate potential design/regulatory/quality risks, and develop actionable strategies following the latest industry and regulatory best practices and trends. Developing the strategy for and authoring Human Factors sections for health authority interactions and submissions. Interact with health authorities during face to face meetings and written responses.Lead human factors development activities for patient-centric device innovationsContribute to new product introduction efforts for parenteral combination product launch and on-market support by applying human factors principles and standard methodologiesCollaborate with external Human Factors consultancies and develop vendor strategy appropriate for the overall parenteral pipeline.Engage with AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and best practices.Lead, mentor and manage a group of HF engineers.Be a voice of user-centricity across all product types in AstraZeneca.Be engaged with and influence Human Factors best practices externally across industry and with regulatorsDevelop and find opportunities for improvement of internal Human Factors practices and associated business processes to ensure consistency, compliance and efficiency with internal business partners and counterpartsEducation & Experience Requirements:Education: Bachelor's or Master's Degree in human factors engineering, bioengineering, mechanical engineering, or related fieldExperience:Bachelor's Degree and 15+ years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development -OR- Master's Degree and 12+ years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development. Required Skills:Advanced knowledge in Human Factors engineering for combination products including a in-depth knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management. Ability to adapt human factors strategies to the evolving regulatory expectations in the combination product space.Experience in health authorities (FDA, EMA, Notified Bodies, and other regulators) submissions and associated interactionsExperience with GxP responsibilities to provide applicable data and reports for health authority submissions and approvals. Familiar with health authority and quality audits.An understanding of the drug/device development process including a balanced perspective on how to integrate Human Factors work into these processes.Ability to build relationships with and manage external Human Factors consultancies to execute research activitiesStrong communication, organizational and technical problem-solving skills with an ability to influence internal stakeholders as well as external industry and health authoritiesAbility to lead a team, create a positive work environment and effectively develop staffWhy AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a biopharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.