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Position Description:

Sr. Design Quality Engineer for Medtronic, Inc located in Northridge, CA. Coordinate and provide process design quality support for the new product development programs by applying methodologies such as Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), and Design for Manufacturing Assembly (DFMA) during process design and development phase. Drive risk mgmt. deliverables by facilitating and generating process failure modes effects analysis (PFMEA) and Hazard Analysis and facilitate and execute process FMEAs. Develop Process Parameters (P-diagram), Input-Process- Output (IPO) matrices, process characterizations, test methods and process validation strategies (IQs/OQs/PQs) and Test Method Validations (TMVs) for new products in development. Use statistical techniques or data analysis including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, Design of Experiments (DOEs), Gauge R&R (GR&R), to inform design decision making and conclusions for deliverables like test method validations, process characterizations and verification, process validation and reliability demonstration activities. Navigate various government and industry standards for the development and use of medical devices including FDA QSR (Quality Systems Regulations), ISO13485, ISO14971, and EU Medical Device Regulations (EU MDR). Utilize Good Manufacturing Practices (GMP). Coordinate Design Control, Design Verification and Process Validation. Coordinate Root cause investigations and Corrective and Preventive Actions (CAPA). Relocation assistance is not provided #LI-DNI.

Basic Qualifications:

Master’s degree in Mechanical Engineering, Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing or quality engineer or related occupation for medical devices Must possess at least two (2) years of experience with each of the following: DRM, DFSS, and DFMA, PFMEA, Hazard Analysis, and FMEAs; Developing Process Parameters, Process Development, DOE, test methods, IQ/OQ/PQ, and TMV for new product development; Performing data analysis to include hypothesis testing, confidence and tolerance intervals, regression, capability analysis, and GR&R; FDA QSR, ISO13485, ISO14971, and EU MDR; GMP; Design Control, Design Verification and Process Validation, Root cause investigations, and CAPA.

Salary: $94,400 to $141,600 per year

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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.

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