Senior Post-Market Surveillance Engineer

Imricor Medical Systems Inc•Burnsville, MN

6h•$110,000 - $132,000•Onsite

About The Position

This Senior Post-Market Quality Engineer position is responsible for ensuring the safety, effectiveness, and regulatory compliance of marketed medical devices throughout their lifecycle. This role supports post-market data analysis and trending, complaint handling, post-market surveillance plans/reports, corrective and preventive action (CAPA), risk management, and other activities. This position collaborates cross-functionally with Regulatory, Clinical, Operations, and R&D to identify trends, investigate product issues, and implement quality improvements that enhance patient safety and product performance.

Requirements

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.

Responsibilities

Collect, analyze, trend, and present post-market data
Evaluate post-market data to identify emerging issues and drive continuous improvement efforts
Initiate and support Corrective and Preventive Actions (CAPA) resulting from complaints, audits, trending, and other post-market information
Authors post market surveillance plans/reports and periodic safety update reports (PSUR).
Support evaluation of complaints for reportability under applicable FDA, EU MDR, and other global reporting requirements
Conduct and support complaint investigations to determine root cause and product impact
Support Health Hazard Evaluations (HHE) and assessment of product issues that may require field actions
Participate in internal/external audits and support responses related to post-market activities
Review and update risk management files based on post-market data in accordance with ISO 14971
Performs other related duties and responsibilities, as assigned.