Position Description:

Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971. Demonstrate understanding of design and manufacturing of electro-mechanical catheters. Navigate the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). Updating Process Failure Mode Effect Analysis and Design Failure Mode Effective Analysis (PFMEA and DFMEA) and root cause analysis (RCA). Identifying and driving Value engineering and yield improvement projects. Leverage Lean Six Sigma processes, DOE (Design of Experiments) with statistical analysis and Design for Manufacturing and assembly (DFMA), to ensure product meets quality requirements. Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV). Provide insight and ownership for documentations for Non-conforming Material Report and CAPA (Corrective and Preventative Action). Navigate CAD (Computer-Aided Design) Tools including SolidWorks for equipment and fixture drawings. Coordinate Manufacturing Processes and Line clearance for Standard Operating Procedures. _Relocation assistance is not available for this position_ .

Basic Qualifications:

Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing engineer or related occupation; or, Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a manufacturing engineer or related occupation. Must possess at least two (2) years of experience with each of the following: development and optimization of products, processes, tooling, and equipment; FDA QSR, 21 CFR Part 820, ISO 13485, and ISO 14971; GMP and GDP; PFMEA, DFMEA, and RCA; DOE and DFMA; execution of IQ/OQ/PQ, Gage R&R, and TMV; Lean Six Sigma, NCMR and CAPA; and CAD Tools. _Relocation assistance is not available for this position._

Salary: $127,900 to $146,400 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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