Post Market Surveillance Engineer

Description

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

OVERVIEW:

 The Post Market Surveillance Engineer is responsible for performing technical complaint investigations and post-market engineering analyses to support regulatory compliance, patient safety, and continuous product improvement. 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. 

Requirements

ESSENTIAL DUTIES AND 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.
• 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.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• 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.
• 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.

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
• 2+ years of experience in quality systems in the medical device or pharmaceutical / biotech industry.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.

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.