HR Representative Salary in Santa Rosa, CA

Principal Regulatory Affairs Specialist - Structural Heart and Aortic, Mitral and Tricuspid (hybrid)Come be a part of one of the most exciting therapy areas within Medtronic, supporting the Transcatheter Mitral and Transcatheter Tricuspid (M&T) programs within the. The M&T space is one of the fastest growing businesses in the medical device industry and is expanding rapidly to serve patients globally. To meet this need, we are adding to our world-class M&T Regulatory Affairs team and looking to hire a Principal Regulatory Affairs Specialist to make an immediate impact for patients with our novel, breakthrough technologies.At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.The preference is for this position to be based in Santa Rosa, CA or Mounds View, MN.Careers that Change LivesReporting to the Senior Manager, the Principal Regulatory Affairs Specialist will support Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle. The Prin. RA Specialist will execute regulatory filings to support this strategy such as FDA Pre-Submissions, PMDA Consultations, IDEs, PMAs, 510(k)s, Technical Files, etc. Being a driven individual and strong communicator is key for this role and the successful candidate should be comfortable working in novel areas to ensure projects continue to gain momentum and meet milestones. Ideally, this candidate will have experience supporting software development programs, at minimum software in a medical device (SiMD) with proficient working knowledge of cybersecurity and interoperability requirements.Additionally, the Principal Regulatory Affairs Specialist is expected to play a key role in the mentoring of junior team members and to be an active participant in the development and training of the Regulatory Affairs team. The individual will work in collaboration with Regulatory Affairs Team members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, and EU MDR Technical Documentation in addition to Change Management assessments. The successful candidate will actively support advertising and promotion activities for commercial products across the portfolio, may support audit and compliance activities as needed and support business development activities/needs as they arise. Candidates that will be successful in this role thrive in a dynamic and priority driven environment that requires creative strategies fostered by a culture that encourages close collaboration with colleagues, new approaches that yield constructive, unconsidered insights and ability to mentor and develop more junior members of the team.A Day In The Life Represents the Regulatory Affairs function on product development teams, bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program. Partners with cross-functional team members to lead engagements with regulatory agencies for new and existing devices. Leads and influences the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, and change management implementation. Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes. Acts as a mentor to colleagues within the team and effectively manages an extended team. Stays current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements. Works with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones. Partners in problem resolution in an effort to mitigate functional/ program level challenges to keep objectives moving in line with program estimates. Works within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence. Must Have (minimum requirements)To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor's degree. Minimum of 7 years of direct Regulatory Affairs experience within the medical device industry Or advanced degree with a minimum of 5 years of Regulatory Affairs experience within the medical device industry Desired/Preferred Qualifications Direct Regulatory Affairs experience supporting programs throughout software development life cycle. Medical device industry experience with Class II/III/IV products. Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc.,) and associated regulatory filings in the U.S., EU, and globally. Experience performing advertising and promotion reviews/approvals for medical devices. Experience engaging regulatory bodies. Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). Analytical, process and data visualization experience Working knowledge of Project Management methodologies and tools; PMP certification is an asset. Demonstrated strong business acumen and planning. Strong interpersonal, quantitative analysis, and problem-solving skills. High degree of initiative and influence management skills Excellent written and oral communication, technical writing, and editing skills. Experience working in a virtual team environment in supporting cross-functional teams remotely. Results oriented. Ability to drive to completion in adherence to aggressive project schedules. Ability to manage multiple projects and proficiency with Microsoft Office and software tools. About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Senior Principal Reliability Engineer Careers that Change Lives At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.The Senior Principal Quality Engineer is responsible for the owning and executing post market surveillance activities. Furthermore, this role is responsible for overall operation of Post Market Quality specifically overseeing the execution of Patient Risk Management, Complaint investigations, CAPA's etc within the SHA operating unit (Structural Heart and Aortic). See additional responsibilities section for more details.The Structural Heart and Aortic integrated operating unit offer minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves-aortic, pulmonic, mitral, tricuspid-and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta. Key Technologies: Endurant I/II/IIs Stent Graft systemsValiant Captivia Stent Graft systemsNavion Stent Graft systemsReliant Balloon CatheterHeli-FX Endoanchor systemThis position is within the Structural Heart and Aortic (SHA) operating unit and is open to remote candidates.We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. A Day in the Life In general, the following responsibilities apply for the Senior Principal Quality Engineer. This includes, but is not limited to the following:• Develops solutions to unique issues with wide range of difficulty. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection.• Interacts and strongly influences with internal and external customers at various levels including executive leadership on significant matters.• Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.• Implements strategic goals established by functional leadership. Self-Initiates discussions with management, Field Assurance, and Quality Assurance (QA) via the product quality meetings or other appropriate forum, when new failure mode trends are identified, providing evidence-based approach and strong engineering depth.• Develop and lead robust process for identifying and monitoring root cause failure modes, frequency, and severity. Provide statistical data to Field Assurance, QA, and management on product performance, effectively describing clinical observations and the relationship with device performance.• As necessary, proposes changes to improve system and/or process reliability• Frequently provides guidance, coaching and training to other employees. MUST HAVE - MINIMUM REQUIREMENTS: TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME• Bachelor's degree in engineering, health science, or a technical discipline• Minimum of 10 years of work experience in Engineering, Science, OR Advanced degree in Engineering, Science, or technical discipline with 8 years of work experience. Nice to Have • Advanced degree in engineering, science, or equivalent technical discipline• Demonstrated understanding of implant procedures.• Experience in a highly regulated industry, preferably implantable medical devices• Knowledge of product development cycles including clinical and regulatory requirements About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.Base pay is based on numerous factors and may vary depending on job-relatedknowledge, skills, and experience.

Position Summary: Supports all aspects of the optical manufacturing process. This includes, but is not limited to, coating, metrology, fabrication, parts cleaning & assembly, incoming and final inspection, data interpretation, and data entry. All duties require a commitment to safety, quality, accuracy, and execution with excellence through continuous improvement, performance, integrity, and respect for people and the Company's mission. Ideal candidates will possess the following traits/skills: excellent interpersonal skills, be professionally mature and honest in their conduct, have good verbal and written communication skills, be highly detail oriented, driven to learn & improve processes, flexible/agile, reliable, and be a team player. Key Responsibilities: Works as a team player supporting all shift work activities Works within and across all operations departments as assigned, including but not limited to: Assembly, Cleaning, Coating, Fabrication, Final Quality Inspection, Marking, Metrology Follow instructions and procedures precisely while offering suggestions for continuous improvement Handle fragile product & parts ranging in size from 1 millimeter to 450 millimeter and weight from less than 1 gram to 25 kilograms Maintains housekeeping, sanitation, and Good Manufacturing Practices (GMP) requirements Perform product and machine inspection Analyzes data, reports abnormalities to appropriate person/department Assemble fixtures, parts, tooling, calibrate tools/machines Clean product, parts, tooling, machines, work area Adhere to Company quality policy, environmental policy, sustainability policy, and safety programs Use Microsoft Suite (Excel, Outlook, Teams, e-mail, O365, etc.,) and other manufacturing programs Performs other duties as assigned by supervisor/management Must maintain satisfactory attendance, to include timeliness MINIMUM QUALIFICATIONS: High School diploma or equivalent Basic computer skills; comfortable with machinery Basic math skills adding, subtracting, multiplying, and dividing including percentages and decimals; can understand basic geometric concepts e.g., angles and shapes Can multitask and work with a high degree of accuracy, high attention to detail U.S. Person per EAR Part 772 AND ITAR 120.15 PREFERRED EXPERIENCE: Experience in optical manufacturing and/or any manufacturing environment; experience in optical coating, metrology, disposition, cleaning, parts assembly, fabrication a plus Mechanical/scientific aptitude or interests Self-starter/works well alone and with limited supervision Team oriented and driven to meet goals and improve processes Skilled in reading, comprehending, interpreting, and executing detailed instructions, short correspondence (e.g., e-mails, texts, instant messaging) Skilled in writing simple, informational, and technical correspondence Familiar with lean manufacturing methods/tools (5-s, root cause analysis, continuous improvement cycle) Some college, Associates Degree in any of the sciences; mechanical, electrical, physics, engineering technology preferred Comfortable around machinery & computers Experienced and certified forklift driver WORKING CONDITIONS: Work within a manufacturing environment Will sit 20%-90% of time / stand 10%-80% of time depending on job assignment Be able to use hands to handle delicate product and very small objects in addition to tools, equipment, or controls Be able to reach overhead and work on a ladder/elevated heights Be able to work in various positions, including but not limited to, reaching, stooping, standing, bending over, sitting, kneeling, and squatting for extended periods of time Required to wear a respirator, when necessary Be able to work extended hours (overtime) when required Be able to lift, pull and push materials and equipment to complete assigned job tasks Use of solvents and cleaning substances, lasers, sharp objects, & high heat equipment Must be able to lift and/or move 35 pounds of weight on occasion Clarity of vision to see close and mid-range Temperature is moderate within work environment The noise level in the manufacturing environment is moderate, but occasionally can be loud The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Company Summary: Alluxa is a technology company that provides specialized optical filters and thin-film precision coatings for the most challenging applications in the industrial technology, life sciences, and semiconductor markets. The company's products are developed through a proprietary coating process using state-of-the-art, advanced equipment. Alluxa partners with customers across major end markets to provide customized, complex precision coating solutions through Alluxa's specialized technology platform and proprietary processes. Learn more about Alluxa: https://www.alluxa.com/why-alluxa/ Alluxa is a subsidiary of Enpro, a leading industrial technology company using material science to push boundaries in semiconductor, life sciences, and other technology-enabled sectors. We are a leader in sealing technologies, advanced surface technologies, and highly engineered materials. Our products and services are sold into more than 40 distinct end-markets that touch our lives every day - from food and pharmaceutical facilities to semiconductor clean rooms, from agricultural robots that help grow your food to last-mile technologies that deliver it to your doorstep, from commercial aviation to space exploration, and much more in between. Our commitment to innovation, quality, and value has propelled our brands to wide recognition and leading positions in their markets. Alluxa/Enpro is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Alluxa/Enpro carefully considers a wide range of compensation factors including the background, education, training, and experience required, as well as geographic considerations such as cost of labor, and applicable local and state laws. These considerations can cause offered compensation to vary. The hiring range for this position is typically $18.00/hr - $28.00/hr. Actual offer will be based on the individual candidate. Bonuses and/or incentives may be eligible for this position. Alluxa/EnPro offers a range of benefits including, but not limited to medical, dental, vision, life, 401(k) matching, and other supplemental insurance options.