Post Market Surveillance Associate Engineer

About the role

The Post Market Surveillance Associate Engineer at RxSight® is responsible for investigating technical complaints and conducting post-market engineering analyses to ensure regulatory compliance, patient safety, and product improvement.

Responsibilities

• 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.
• Audit and audit request support related to complaint handling and post-market activities.
• Assist with 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.

Requirements

• Strong verbal and written communication skills.
• Excellent organizational and time management abilities.
• Demonstrated learning agility and technical curiosity; proactively builds product and process understanding and translates insights into practical improvements.
• 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).
• Working knowledge of: Design principles, CAD and engineering drawings, Geometric Dimensioning and Tolerancing (GD&T) concepts.
• Proficiency with standard office software and technical documentation tools.
• Familiarity with FDA Quality Management System Regulation (21 CFR Part 820) and/or ISO 13485.

Education, Experience, And Training

• 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.

Salary

$75,000 To $85,000 Per Year