Post Market Surveillance Associate Engineer

OVERVIEW

The Post Market Surveillance Associate Engineer is responsible for performing technical complaint investigations and post market engineering analyses to support regulatory compliance, patient safety, and continuous product improvement. This role is best suited for an engineer who is hands on, curious, and eager to learn the product and underlying technology - then apply those learnings to strengthen designs, processes, and product performance.

The role applies engineering principles, risk management, and root cause analysis methodologies to marketed ophthalmic implants, instruments, and other products, ensuring timely and compliant resolution of post-market issues.

• Perform complaint product analysis, testing, and evaluation in accordance with internal procedures and regulatory requirements.
• Execute hands on bench/lab testing (as needed) to support complaint investigations, including developing or refining test methods/fixtures and documenting results.
• Conduct root cause investigations using sound engineering and problem-solving techniques.
• Perform risk assessments, complaint trend analysis, and complaint history reviews.
• Escalate investigation findings appropriately and in alignment with quality system and regulatory expectations.
• Document all investigation activities clearly and compliantly, including technical reports and escalation summaries.
• Draft or support customer-facing investigation responses, when requested.
• Collaborate cross-functionally with Engineering, Quality, Regulatory, Manufacturing, Customer Service, and Clinical/Medical Affairs teams.
• Support CAPAs, HHEs, NCRs, and other quality system processes, as required.
• Assist with audits and audit requests related to complaint handling and post-market activities.
• Support engineering and continuous improvement for products currently on the market.
• Contribute to the development, revision, and training of procedures, work instructions, and technical documentation.
• Meet complaint handling timelines, KPIs, and departmental performance metrics.
• Support the ad-hoc generation of complaint data and metrics, as needed.
• Maintain current working knowledge of evolving local, US, and international guidance and regulations for the medical device industry.
• Participate in special projects and initiatives, as assigned.
• Assist with mentoring new team members.

• Strong verbal and written communication skills.
• Excellent organizational and time management abilities.
• Ability to analyze technical data and synthesize findings clearly.
• Working knowledge of:
• Design principles
• CAD and engineering drawings
• Geometric Dimensioning and Tolerancing (GD&T) concepts
• Demonstrated learning agility and technical curiosity; proactively builds product and process understanding and translates insights into practical improvements.
• Takes ownership of investigations and engineering deliverables (plans, testing, analysis, conclusions), with a bias toward clear, evidence-based closure.
• Hands‑on experience executing bench/lab test methods and documenting work in a clear, traceable manner (e.g., protocols, raw data, calculations, and concise technical summaries).
• Comfortable working with common measurement tools and lab instrumentation; able to set up experiments, troubleshoot test issues, and verify data quality.
• Working knowledge of data analysis for investigations (e.g., descriptive statistics, run charts, and basic hypothesis‑driven comparisons).
• Ability to work effectively in a cross‑functional, fast‑paced environment.
• Proficiency with standard office software and technical documentation tools.
• Familiarity with FDA Quality Management System Regulation (21 CFR Part 820) and/or ISO 13485.

• 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.
• Prior experience supporting complaint handling, medical device reporting, post‑market activities, or related work in a highly regulated environment preferred.
• Training to be completed per the training plan for this position.