Principal R&D Engineer

Medtronic • San Diego, CA

3d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life As a member of the R&D Mechanical Engineering group in the Diabetes Business Unit, the individual selected for this role will be responsible for sustaining commercial products and process of diabetes related products such as insulin pumps, glucose sensors, and smart insulin pens. The Principal R&D Engineer will also strongly influence technology and process development for new products and support design transfer activities to contract manufacturers for commercial launch. The individual will leverage strong knowledge of medical device regulations and experience with quality management systems to drive successful outcomes. The ideal candidate for this position has experience in medical device design, process development, and characterization testing and has a strong background in Design Controls. In addition, the Principal R&D Engineer has driven Design Reviews, inclusive of both New Product Introduction (NPI) and Design Changes for commercial products, and has maintained Design History Files (DHF). This individual has experience in medical plastics and electromechanical assemblies. The ideal candidate has a background in process qualifications including Test Method Validation (TMV) and Design Verification Testing (DVT). This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Operations, Quality and Regulatory to assure the successful execution of business goals. The person filling this role will become part of a dynamic and fast-paced R&D group with a strong history of successful product development. As a member of the R&D Mechanical Engineering group in the Diabetes Business Unit, the individual selected for this role will be responsible for sustaining commercial products and process of diabetes related products such as insulin pumps, glucose sensors, and smart insulin pens. The Principal R&D Engineer will also strongly influence technology and process development for new products and support design transfer activities to contract manufacturers for commercial launch. The individual will leverage strong knowledge of medical device regulations and experience with quality management systems to drive successful outcomes. The ideal candidate for this position has experience in medical device design, process development, and characterization testing and has a strong background in Design Controls. In addition, the Principal R&D Engineer has driven Design Reviews, inclusive of both New Product Introduction (NPI) and Design Changes for commercial products, and has maintained Design History Files (DHF). This individual has experience in medical plastics and electromechanical assemblies. The ideal candidate has a background in process qualifications including Test Method Validation (TMV) and Design Verification Testing (DVT). This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Operations, Quality and Regulatory to assure the successful execution of business goals. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Requirements

• Bachelor’s degree and a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Nice To Haves

• Experience with the following tools and techniques are beneficial: SolidWorks Minitab Scientific Molding GD&T

Responsibilities

• Works closely with strategic partners and vendors to support current products and initiate new production projects and assist in developing processes/techniques to meet contract objectives.
• Lead technical communications with internal and external stakeholders in support of process improvements and associated design changes.
• Perform product and process development activities of diabetes management products, including creating plans and reports and routing for approvals in an eDMS.
• Understanding of medical device design control process; lead design reviews and ensure on-time completion of Design Control deliverables.
• Lead and perform process characterization, support design verification / testing, and support test method development and associated Test Method Validation (TMV) activities.
• Perform Statistical analysis (DOE, Capability Analysis, GR&R ...)
• Provide guidance and mentorship to junior engineering staff.
• Apply methodologies such as Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), and Design for Manufacturing Assembly (DFMA).
• Help develop specifications, test methodologies, and test equipment to evaluate design concepts.
• Perform calculations, analyses, and engineering testing to characterize and verify the designs and design changes.
• Equipment selection, tooling and fixture development, procurement, installation and qualification.
• Help ensure designs meet and exceed product specifications, regulatory requirements, and international standards.
• Support corrective and preventive actions with appropriate and detailed follow up.
• Provide technical feasibility assessments.
• Travel to vendor locations and manufacturing sites as needed to help diagnose design problems and ensure programs meet deadlines and troubleshooting issues.
• Present technical findings or project status to cross functional teams and management through meeting minutes, design reviews, presentations and other means of communication.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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.
• 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).
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees