Sr. Quality Engineer - Post-Market Vigilance - Onsite

Medtronic • Irvine, CA

2d • $98,400 - $147,600 • Hybrid

About The Position

At Medtronic Neuroscience, the Senior Quality Engineer provides engineering leadership for evaluating and resolving post-market product quality and safety issues across the Neurovascular portfolio. The role applies product design knowledge, engineering analysis, risk management, statistics, and data analytics to characterize device performance, investigate field-reported failure modes, determine root causes, and assess potential patient and product impact. It works closely with cross-functional partners to turn post-market signals into technically sound risk controls, product improvements, and sustained product reliability while maintaining compliance with applicable regulatory requirements.

The position is based on-site in Irvine, California, four days per week, with the option to work remotely one day per week of the employee’s choosing.

Requirements

• Bachelor's degree with at least 4 years of experience, or Master's degree with at least 2 years of experience, or Ph.D. with 0 or more years of experience.
• Strong statistical data analysis skills, including the ability to analyze complex data sets.
• For Baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Lead engineering evaluations of post-market complaints and product performance signals, including assessment of device failure modes, use conditions, patient impact, and potential product risk.
• Plan and lead complex technical investigations using engineering problem-solving methods, product and process knowledge, returned-device analysis, test data, manufacturing records, and supplier information.
• Develop and document technically supported root-cause and failure-mechanism conclusions, including evaluation of evidence, limitations, and residual uncertainty.
• Partner with R&D, Manufacturing Engineering, Supplier Quality, Regulatory, Clinical, Marketing, and Operations to define containment, product controls, corrective actions, and design or process improvements based on investigation findings.
• Apply design-control and risk-management principles throughout the product lifecycle to assess whether post-market information changes known hazards, failure modes, risk estimates, or the adequacy of existing controls.
• Review and develop engineering test strategies, protocols, methods, and reports to ensure evaluations are technically appropriate, statistically sound, and sufficient to support quality and regulatory decisions.
• Perform complaint trending, signal detection, and data analysis to identify emerging product performance issues and distinguish meaningful signals from expected variation.
• Translate engineering evidence into clear technical recommendations for Product Evaluation Boards, health hazard analyses, product hold decisions, field corrective actions, and other escalation pathways.
• Use large and complex data sets to characterize failure patterns by product, lot, component, manufacturing process, clinical use, and other relevant engineering variables.
• Maintain working knowledge of Neurovascular device design, materials, manufacturing processes, clinical use, and applicable FDA and international medical device requirements and standards.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance or reimbursement; and the Simple Steps global well-being program.
• For all regular employees: incentive plans; 401(k) plan with 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: Senior