Sr. Quality Engineer - Post-Market Vigilance - Onsite

We anticipate the application window for this opening will close on - 16 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic Neuroscience, we bring innovation, expertise, and purpose together to improve outcomes and transform lives for people living with neurological, spine, and chronic pain conditions. Our Neurovascular Operating Unit advances stroke and cerebrovascular care through innovative, minimally invasive technologies that enable rapid, life-saving intervention. From restoring blood flow to securing complex vascular conditions, our solutions help clinicians achieve better outcomes when every second counts. Check us out on LinkedIn: Medtronic Neurovascular 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. Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. This position is on-site in Irvine, CA 4 days/week, with the option to work 1 day/week of your choosing remote. 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social