Senior Quality Engineer

We anticipate the application window for this opening will close on - 9 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 Medtronic's Interventional Cardiology Therapies (ICT) operating unit is seeking a Senior Quality Engineer to lead and execute post market surveillance activities while serving as a key technical leader within Post Market Quality. This role provides strategic oversight of complaint investigations, complaint trending, risk assessments, regulatory support activities, and quality system improvements across the ICT operating unit. The Senior Quality Engineer will serve as a subject matter expert for post-market quality processes and partner closely with Regulatory Affairs, Clinical Affairs, Medical Safety, R&D, Manufacturing, and Global Quality to evaluate product performance, identify emerging risks, and drive continuous improvement initiatives. The role will also provide mentorship to junior engineers and influence quality strategy for new and released products. This position is in Santa Ana, CA and requires on-site presence for 4 days a week. This position is not open to remote candidates or sponsorship. Responsibilities may include the following and other duties may be assigned: Lead complex complaint investigations, product performance assessments, and root cause analyses for commercially released products Drive periodic complaint trending activities, identify and evaluate emerging quality signals, assess patient and business risk, and recommend appropriate actions Provide technical leadership in evaluating complaint data, post-market surveillance information, and field performance trends to support risk management activities Collaborate with cross-functional teams including Customer Quality Experience Management, Clinical Affairs, Medical Safety, Regulatory Affairs, R&D, Manufacturing, and Reliability Engineering to resolve complex quality issues Lead quality assessments supporting regulatory submissions, product registrations, regulatory inquiries, and responses to health authority requests Serve as a subject matter expert for post-market surveillance and complaint handling processes during internal and external audits Partner with Design Assurance and Risk Management teams to review and evaluate risk files, hazard analyses, FMEAs, benefit-risk assessments, and post-market surveillance strategies Lead development, maintenance, and continuous improvement of Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-up activities, and other post-market regulatory deliverables Identify opportunities for process improvement and lead initiatives that enhance quality system effectiveness, operational efficiency, and product quality Provide technical guidance and mentoring to engineers and investigators while promoting best practices in problem solving and risk-based decision making Influence quality decisions through sound engineering judgment, data analysis, and effective communication with leadership and cross-functional stakeholders Prioritize and communicate significant quality concerns, emerging risks, and compliance issues to management and executive leadership as appropriate Participate in CAPA, nonconformance, and risk evaluation activities, ensuring robust investigation, containment, and corrective actions Preferred Qualifications Advanced degree in engineering, science, or equivalent technical discipline Knowledge of cardiovascular/implant procedures Experience with post-market surveillance requirements, complaint handling, risk management, and product performance monitoring Experience with statistical analysis, data trending, and signal detection methodologies Experience in a highly regulated industry, preferably implantable medical devices Knowledge of product development cycles including clinical and regulatory requirements Demonstrated leadership of cross-functional projects and process improvement initiatives Required Qualifications Bachelor’s degree in engineering, health science, or a technical discipline Minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience 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 wi