We anticipate the application window for this opening will close on - 15 Apr 2025 Position Description: Principal Process Engineer for Medtronic, Inc. located in Santa Ana, CA. Multiple positions available. Work within the Process Development group and collaborate with R&D and Design Assurance to bridge concept to commercialization gap for products in the development pipeline; act as the technical contributor and coordinator for the design and development of manufacturing processes for new and iterative heart valve therapies from concept through design transfer and product launch; coordinate process technology implementation into pilot manufacturing and commercial lines where applicable; conduct exploration and development of new process technologies for tissue processing and valve manufacturing; support new product development by designing and developing pilot manufacturing processes, including equipment/fixture/tooling and process characterization and specification development, as well as executing engineering builds for design validation (DV), clinical studies and regulatory submissions; coordinate and execute design & manufacturing transfer of pilot line to commercial production per Operations transfer strategy and Manufacturing Validation Plan (MVP), including installation qualification, operational qualification, and performance qualification, and Test Method Validation (IQ/OQ/PQ/TMV), manufacturing documentation, process risk mgmt. & failure mode and effect analysis (FMEA), and product/process support via operator/engineering training, trouble-shooting/root cause investigation (RCI); utilize tools and concepts in Design for Reliability and Manufacturability (DRM) and Lean Six Sigma, such as requirements flow down, Design of Experiment (DOE), Measurements System Analysis (MSA), Statistical Process Control (SPC), predictive modeling, correlation studies, Minitab Hypothesis Testing, and Process Capability Studies to advance manufacturing quality and reliability; utilize SOLIDWORKS for tooling and fixture development and concept development for process automation; work in ISO Class 7 and 8 cleanrooms for implantable medical devices; employ project mgmt. methodologies and tools to ensure timely completion of project deliverables and efficient allocation of resources, such as mgmt. of project plans/contracts, schedules, and project budget, as well as utilization of data visualization techniques through software programs (i.e. Power BI) to effectively communicate project progress and financial performance to stakeholders and negotiate for resources as needed; navigate the complexities of ISO standards for product/process design and development, including ISO 13485, ISO 5840, and ISO 14971, as well as regulatory requirements per FDA 21 CFR (US), Medical Device Directive (MDD) & Medical Device Regulations (MDR) (EU), Pharmaceuticals and Medical Device Agency (PMDA) (Japan), and Therapeutics Products Directorate (TPD) (Canada). *Position works a hybrid model and will be onsite in Santa Ana, CA four (4) days per week. Relocation assistance not provided. #LI-DNI. Basic Qualifications: Bachelors’ Degree or foreign equivalent in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of progressive post-baccalaureate experience as a process or manufacturing engineer or related occupation for medical devices. Must possess at least five (5) years’ experience with each of the following: Developing process technologies for tissue processing and valve manufacturing; Design and development of pilot manufacturing processes, utilizing DRM, Lean Six Sigma, requirements flow down, DOE, MSA, SPC, predictive modeling, correlation studies, Minitab Hypothesis Testing, Process Capability Studies, and SOLIDWORKS; Executing engineering builds for DV, clinical studies, and regulatory submissions; Design & manufacturing transfer of pilot line, including IQ/OQ/PQ/TMV, Process Risk Mgmt. & FMEA, process and production support, operator and engineering training, troubleshooting, and RCI; ISO Class 7 and 8 cleanrooms for implantable medical device; Project contracts/planning, operational budget, data visualization for stakeholders, and financial reports and resource negotiation; and ISO 13485, ISO 5840, and ISO 14971 standards and FDA 21 CFR, MDD or MDR (EU), PMDA (Japan), and TPD (Canada). Salary: $131,000 to $178,800 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **Welcome to our new Careers Site!** **If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com