Sr. Quality Engineer - Post-Market Vigilance - Onsite

Description

We anticipate the application window for this opening will close on - 11 Nov 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.
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• 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 Security details) during early stages of the hiring process. Any such requests are not legitimate.
• If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
• If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com .
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Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00
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• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
• The following benefits and additional compensation are available to those regular employees who work 20+ 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/reimbursement , and Simple Steps (global well-being program).
• The following benefits and additional compensation are available to all regular employees: 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) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
• Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
• Further details are available at the link below:
• Medtronic benefits and compensation plans
• It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
• If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.