Senior Quality Engineer - Post-Market Risk & Analytics

Regulatory Jobs; Irvine (CA); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic Neurovascular in Irvine, CA is seeking a Senior Quality Engineer to lead post-market quality investigations and risk assessments across the Neurovascular portfolio. You will partner with R&D, Manufacturing, Regulatory, Clinical, and Operations to translate signals into effective containment and product improvements.

This on-site role emphasizes data analytics, root cause analysis, and adherence to FDA and international standards, with collaboration across multiple teams to ensure

Qualifications

• 4+ years of experience with a Bachelor's Degree or 2+ years with a Masters or 0+ years with a Ph.D.
• Strong statistical data analysis skills with ability to analyze complex data sets.
• U.S. work authorization sponsorship requirements for certain roles.

Responsibilities

• Lead engineering evaluations of post-market complaints and product performance signals.
• Plan and lead complex technical investigations using data, tests, and records.
• Develop documented root-cause conclusions with evidence and uncertainties.
• Define containment, product controls, and corrective actions with cross-functional teams.
• Apply design control and risk management through the product lifecycle.
• Review test strategies, protocols, methods, and reports.
• Perform complaint trending and signal detection from large data sets.
• Translate engineering evidence into recommendations for decision boards.
• Maintain knowledge of Neurovascular device design and FDA requirements.

Skills

Statistical data analysis

Education

Bachelor's degree

Master's degree

PhD

Job description

Medtronic Neurovascular in Irvine, CA is seeking a Senior Quality Engineer to lead post-market quality investigations and risk assessments across the Neurovascular portfolio. You will partner with R&D, Manufacturing, Regulatory, Clinical, and Operations to translate signals into effective containment and product improvements.

This on-site role emphasizes data analytics, root cause analysis, and adherence to FDA and international standards, with collaboration across multiple teams to ensure