Senior Post-Market Quality Engineer, Neurovascular

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 investigations, apply design controls, risk management, and data analytics to ensure patient safety and regulatory compliance.

The role partners with R&D, Manufacturing, Regulatory, and Clinical teams to translate post-market signals into robust risk controls and product improvements, ensuring reliable device performance in a fast-paced medical technology environment.

Qualifications

• 4+ years of engineering experience with a degree, or 2+ years with a master's, or 0+ years with a Ph.D.
• Strong statistical data analysis skills applied to complex data sets.
• Experience with design control and risk management in medical devices.

Responsibilities

• Lead engineering evaluations of post-market complaints and product performance signals.
• Plan and lead complex technical investigations using diverse data and records.
• Develop root cause conclusions with clear evidence and remaining uncertainties.
• Define containment, product controls, and corrective actions with cross-functional teams.
• Translate evidence into recommendations for risk analyses and post-market actions.
• Use large data sets to characterize failure patterns across products and processes.
• Maintain knowledge of Neurovascular device design and regulatory requirements.

Skills

Statistical data analysis

Root cause analysis

Cross-functional collaboration

Quality/regulatory awareness

Education

Bachelor's Degree

Master's Degree

Ph.D.

Job description

Medtronic Neurovascular in Irvine, CA is seeking a Senior Quality Engineer to lead post-market investigations, apply design controls, risk management, and data analytics to ensure patient safety and regulatory compliance.

The role partners with R&D, Manufacturing, Regulatory, and Clinical teams to translate post-market signals into robust risk controls and product improvements, ensuring reliable device performance in a fast-paced medical technology environment.