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Position Description:

Systems Engineer for Medtronic, Inc located in Boxborough, MA. Develop and evaluate designs which meet defined product requirements and that are optimized for manufacturability, reliability, and overall cost to the business; utilize DMAIC (Define, Measure, Analyze, Improve, and Control) or DRM (Design, Reliability, and Manufacturability) methodology and Six Sigma to suggest design or manufacturing process improvement; navigate the complexity of industry regulations to include ISO 13485:2003, ISO 14971:2007 and IEC 60601-1; coordinate risk activities to contribute in medical device development, related processes, and GMP (Good Manufacturing Practices); responsible for user interviews, development of user needs and generation of design criteria; coordinate requirement flow-down process and requirement traceability utilizing requirement tool such as Cognition Cockpit (or similar system) and develop the templates for flow-down; provide expertise in manufacturing process development, Equipment Qualification/ Installation Qualification (EQ/IQ) and provide relevant training; utilize statistical tools, including Minitab; evaluate medical product/process using techniques such as DOE (Design of Experiment), Ranging Studies, ANOVA, regression analysis, QMS (Quality Management System), and FDA 21 CFR Part 820; troubleshoot manufacturing or other product-related issues utilizing problem solving techniques, including 5 Why’s and Ishikawa (Fishbone); and address non-conformances in the manufacturing process, investigate root-cause, and disposition plan. Relocation assistance not available. Position works a hybrid model and will be onsite in Boxborough, MA location – 3-4 days per week.

Basic Qualifications:

Masters’ Degree in Mechanical, Industrial, or Biomedical Engineering, Bioengineering or related engineering field and one (1) year of experience as a systems engineer, R&D engineer, Biomedical engineer or related occupation in medical device product development. Must possess a minimum of one (1) year of experience with each of the following: DMAIC or DRM methodology, and Six Sigma; ISO 13485, ISO 14971, and IEC 60601-1; User interviews, development of user needs and generation of design criteria; Requirement Flow-down process and requirement traceability; Manufacturing process development and EQ/IQ; DOE, Ranging Studies, ANOVA, and regression analysis; 5 Why’s & Ishikawa (Fishbone); Addressing Non-conformances in design process, investigating root-cause, and disposition plan.*Relocation assistance not available. Position works a hybrid model and will be onsite in Boxborough, MA location – 3-4 days per week.

Salary: $96,300 to $124,800 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.

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) .

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