Principal R&D Engineer (RPE) - CS

Medtronic • Minneapolis, MN

1d • 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 Principal 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. The Principal R&D Engineer for Medtronic Cardiac Surgery RPE (Released Product Engineering) will be responsible for technical and mechanical design of market-released medical devices. This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. Represent the organization as the prime technical contact on contracts and projects. 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. 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. 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. A Day in the Life: In general, the following responsibilities apply for the Principal R&D Engineer role. This includes, but is not limited to the following:

Requirements

• TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemistry, Materials Science, Electrical Engineering, or related STEM discipline and a minimum of 7 years of technical experience OR a Master’s degree with a minimum of 5 years of technical experience

Nice To Haves

• Relevant experience in the Medical Device Industry including experience with design and development of Class II or III medical devices, and familiarity with medical device regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820)
• Experience performing statistical analysis using Minitab or similar statistical software to support product development and process improvement
• Hands-on involvement in verification testing, including test planning, execution, data analysis, and documentation to ensure compliance with regulatory requirements
• Able to facilitate cross functional group problem solving, decision making, and small projects; including CAPA’s
• Proficiency in 3D CAD modeling software (e.g., Creo, SolidWorks, or equivalent)
• Experience with rapid prototyping techniques and materials selection for medical applications
• Demonstrated ability to conduct design failure mode effects analysis (DFMEA)
• Excellent communication and cross-functional collaboration skills

Responsibilities

• Interact with personnel on significant technical matters often requiring coordination between organizations
• Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses
• Provide critical evaluation of manufacturing and supplier change impact on fielded products
• Initiates change activity to modify maintain design documentation (BOM’s, Specs, drawings)
• Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including CAPA ownership
• Provides RPE input to new product development teams
• Supports and conducts DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications
• Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation
• Collaborates with reliability and manufacturing to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)
• Supports cost reduction and continuous improvement projects
• Provides problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost
• Supports internal and external regulatory compliance audits
• Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverables
• Leads projects of medium complexity and size eg geo expansion and product market introductions.

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