Post Market Surveillance Associate Engineer
$75,000–$85,000 year
On-site · Aliso Viejo, California, United States
Job Summary
The Post Market Surveillance Associate Engineer will perform complaint investigations and post-market engineering analyses to support regulatory compliance, patient safety, and continuous product improvement. The role involves hands-on bench/lab testing, root cause analysis, risk assessments, and collaboration across Engineering, Quality, Regulatory, Manufacturing, Customer Service, and Clinical/Medical Affairs to ensure timely, compliant resolution of post-market issues. Responsibilities include documenting investigations and technical reports, supporting CAPAs and quality-system processes, contributing to procedures and training, and maintaining awareness of evolving FDA/ISO guidance for medical devices.
Required Qualifications
- Bachelor’s degree in engineering from an accredited institution (Biomedical Engineering preferred)
- Experience with or working knowledge of root cause analysis and risk management
- Engineering problem-solving methodologies
- Technical documentation and report writing
- Prior experience of quality systems in the medical device or pharmaceutical/biotech industry preferred
- Training to be completed per the training plan for this position
- Familiarity with FDA Quality Management System Regulation (21 CFR Part 820) and/or ISO 13485
- Strong verbal and written communication skills
- Hands-on bench/lab testing experience and ability to document results clearly
- CAD and engineering drawings proficiency; GD&T concepts
- Ability to analyze technical data and synthesize findings clearly
- Ability to work in a cross-functional, fast-paced environment
- Proficiency with standard office software and technical documentation tools
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