Entry‑Level Post‑Market Surveillance Engineer

Integer Holdings Corporation; Plymouth (MN); On-site; USD 54,000 - 79,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Parental leave

401(k) with company match

Paid time off

Job summary

Integer Holdings Corporation is seeking an Associate Post Market Surveillance Engineer to support complaint handling, regulatory reporting, and post-market activities. You will assist with audits, data collection, and investigation reporting while adhering to FDA and QMS requirements.

The role emphasizes collaboration with cross-functional teams, maintaining documentation, and contributing to continuous quality improvement in a regulated medical device environment.

Qualifications

• Associate’s or two-year degree required.
• 0–3 years of relevant experience preferred.
• Ability to work independently and with cross-functional teams.
• Strong written and verbal communication skills.
• Solid technical aptitude and problem-solving ability.

Responsibilities

• Capture and document complaints in the complaint handling database according to policies.
• Send complaint acknowledgements to customers.
• Track customer return products.
• Support complaint investigations with cross-functional team members and report findings.
• Gather information from internal/external customers for investigations and assist in customer communications.
• Support data collection, root cause investigations and issue resolution for product quality and patient safety.
• Assist timely closure of investigations to comply with FDA and other regulations.
• Collaborate with team and stakehholders to share information and learn.

Skills

Communication skills

Analytical thinking

Documentation

Team collaboration

Education

Associate degree

Tools

Microsoft Office

Job description

Integer Holdings Corporation is seeking an Associate Post Market Surveillance Engineer to support complaint handling, regulatory reporting, and post-market activities. You will assist with audits, data collection, and investigation reporting while adhering to FDA and QMS requirements.

The role emphasizes collaboration with cross-functional teams, maintaining documentation, and contributing to continuous quality improvement in a regulated medical device environment.