Sr. Quality Engineer - Post-Market Vigilance - Onsite

Medtronic•Irvine, CA

7d•$98,400 - $147,600•Hybrid

About The Position

This role provides 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.

Requirements

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.
U.S. work authorization

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 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.
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.