Senior R&D Engineer - CS

Medtronic • Minneapolis, MN

8d • $104,000 - $156,000 • Onsite

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 Senior R&D Engineer Careers That Change Lives At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Medtronic Cardiac Surgery is looking for a Senior Level Engineer to join our R&D Released Product Engineering (RPE) Organization. This role will support commercially released products (Sustaining) activities focused on cardiopulmonary bypass disposables, ablation, cannula, and OPCAB devices. Areas of responsibilities will include mechanical design, design requirements, test requirements and test procedures. Collaborate with other RPE, Regulatory, Manufacturing and Quality colleagues to ensure product issues, compliance concerns, supplier and manufacturing non-conformities are addressed and cost effective. Candidates must be able to understand design implications to changes, write detailed specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment. The Cardiac Surgery Operating Unit develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. This position is in Brooklyn Park, MN. within the Cardiac Surgery (CS) Operating Unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. A Day in the Life In general, the following responsibilities apply for the Senior R&D Engineer role. This includes, but is not limited to the following: Design support for Cardiac Surgery products for medical applications in a regulated environment. Create robust design solutions that address broad development problems involving class II and Class III medical devices and accessories. Support sustaining engineering programs to support new and existing products to ensure sustainable and stable operations of production. Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business. Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business. Document and support decisions using engineering analysis and data. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project management and design for manufacturing practices and adhere to the applicable medical device FDA requirements for design and manufacturing, medical device materials, related processes, and GMP (Good Manufacturing Practices). Utilize statistical tools and methods including Minitab, DOE, SPC, Measurement System Analysis, Variable Gage R & R, attribute agreement analysis, ANOVA, t-test, and regression analysis. Interface with suppliers, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products. Create and communicate project plans, tasks and deliverables, and manage time to meet project deadlines. Lead troubleshooting and problem-solving efforts related to development projects. Support decisions through thorough engineering analysis and data.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Chemistry, Materials Sciences or related STEM discipline and a minimum of 4 years of experience technical experience OR a Master's degree with a minimum of 2 years technical experience

Nice To Haves

• Knowledge and experience using DFMECA FMEA, DOE.
• Knowledge and experience with statistical analysis (Minitab, ANOVA)
• Demonstrated written and verbal communication skills and work cooperatively as part of a team and cross functionally.
• CAD Experience
• Familiarity with these regulations: FDA 21 CFR Part 803, ISO 13485.
• Proven communication skills and ability to lead within a multi-functional team environment
• Ability to solve problems and innovate solutions.

Responsibilities

• Design support for Cardiac Surgery products for medical applications in a regulated environment.
• Create robust design solutions that address broad development problems involving class II and Class III medical devices and accessories.
• Support sustaining engineering programs to support new and existing products to ensure sustainable and stable operations of production.
• Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business.
• Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business.
• Document and support decisions using engineering analysis and data.
• Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements.
• Utilize project management and design for manufacturing practices and adhere to the applicable medical device FDA requirements for design and manufacturing, medical device materials, related processes, and GMP (Good Manufacturing Practices).
• Utilize statistical tools and methods including Minitab, DOE, SPC, Measurement System Analysis, Variable Gage R & R, attribute agreement analysis, ANOVA, t-test, and regression analysis.
• Interface with suppliers, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products.
• Create and communicate project plans, tasks and deliverables, and manage time to meet project deadlines.
• Lead troubleshooting and problem-solving efforts related to development projects.
• Support decisions through thorough engineering analysis and data.

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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level