Senior Post-Market Surveillance Engineer
$110,000–$132,000 year
On-siteBurnsville, Minnesota, United States
Job Summary
Conduct post-market data analysis, trending, and reporting to identify emerging issues and drive continuous improvement. Initiate and support Corrective and Preventive Actions (CAPA) resulting from complaints, audits, and safety trends. Evaluate complaints for reportability under FDA, EU MDR, and global requirements while conducting root cause investigations. Author post-market surveillance plans, periodic safety update reports, and support Health Hazard Evaluations. Review and update risk management files in accordance with ISO 14971 standards. Participate in internal and external audits and collaborate cross-functionally with Regulatory, Clinical, Operations, and R&D teams to enhance patient safety and product performance.
Required Qualifications
- Bachelor's degree in engineering or related field
- 5+ years' experience in Post Market Quality or related field
- Experience working in an EU MDR/FDA/ISO 13485 regulated environment
- Experience in complaint investigations, reporting, risk management (ISO 14971), CAPA, and statistical analysis/trending
- Strong communication skills, both verbal and written
- Must be available to work at our location in Burnsville, MN
- Light work, exerting up to 20 lbs. of force or less
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors
- Requires typing, talking and hearing
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