Senior Post-Market Surveillance Engineer

Description

Supervisor’s Title: Quality Systems Manager
Exempt or Non-Exempt: Exempt

Location: Must be available to work at our location in Burnsville, MN.

Compensation: The expected annual base salary range for this Minnesota-based position is $110,000-132,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function 

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.

Essential Functions: 

• 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.

Requirements

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.

Working Conditions

• 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.

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.