Sr. Quality Engineer - Post-Market Vigilance - Onsite
Medtronic
Summary
In this role, the Senior Quality Engineer will provide engineering leadership for the evaluation and resolution of post-market product quality and safety issues across the Neurovascular portfolio. The engineer will apply product design knowledge, engineering analysis, risk management, statistics, and data analytics to characterize device performance, investigate field-reported failure modes, determine root cause, and assess potential patient and product impact. This role partners closely with R&D, Manufacturing Engineering, Supplier Quality, Regulatory, Clinical, and Operations to translate post-market signals into technically sound risk controls, product improvements, and sustained product reliability while ensuring compliance with applicable regulatory requirements.
Job description
Responsibilities
Engineering Investigation and Issue Resolution
- 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 clear 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.
Product Risk and Post-Market Engineering
- Apply design control and risk management principles throughout the product lifecycle to evaluate 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 strong working knowledge of Neurovascular device design, materials, manufacturing processes, clinical use, and applicable FDA and international medical device requirements and standards.
Required Qualifications
- 4+ years of experience required with a Bachelor's Degree OR 2+ years of experience required with a Masters Degree OR 0+ years of experience required with a Ph.D.
- Strong statistical data analysis skills with ability to analyze complex data sets
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Requirements
- 4+ years of experience with a Bachelor's Degree OR 2+ years of experience with a Masters Degree OR 0+ years of experience with a Ph.D.
- Strong statistical data analysis skills with ability to analyze complex data sets
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization required (roles below Principal level)
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance/Reimbursement
- Incentive Plans
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Retirement Plan Supplement
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.