Associate Risk Management Engineer - Hybrid

Full-time - Entry Level

Minneapolis, MN

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 career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people. Help us engineer the extraordinary! Help bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. We are currently looking for an Associate Risk Management Engineer to join Medtronic Neuromodulation and Pelvic Health to drive the development of safe and effective implantable medical systems and support sustaining activities.

Responsibilities

• Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.
• Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.
• Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Evaluate impact of potential issues to patient safety and product performance.
• Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle.
• Identify and act upon opportunities for continuous improvement of the Risk Management Process.
• Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance.
• Create documentation in compliance with applicable procedures to meet project deliverables.

Requirements

• Requires a Baccalaureate degree in Engineering or technical discipline.

Nice-to-haves

• Experience in the application of statistics.
• Experience in a highly regulated industry, preferably implantable medical devices.
• Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA).
• Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
• Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing.
• Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.

Benefits

• 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
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)