Post Market Surveillance We are seeking a Post Market Surveillance consultant to support technical complaint investigations and post-market engineering activities for regulated medical devices, including ophthalmic implants, instruments, and related products. This position is ideal for an engineer who combines strong analytical and root cause investigation skills with hands-on bench/lab testing experience and a solid understanding of medical device quality systems. Key Responsibilities Perform technical complaint investigations, product analysis, testing, and evaluation in accordance with established procedures and regulatory requirements. Conduct hands-on bench and laboratory testing to support complaint investigations. Develop, refine, and execute test methods and fixtures; document protocols, raw data, calculations, results, and conclusions. Lead root cause investigations using structured engineering and problem-solving methodologies. Perform risk assessments, complaint trend analyses, and complaint history reviews. Analyze technical data and develop clear, evidence-based conclusions. Escalate investigation findings in accordance with Quality System and regulatory requirements. Prepare compliant technical investigation reports, summaries, and supporting documentation. Support customer-facing investigation responses as needed. Partner cross-functionally with Engineering, Quality, Regulatory, Manufacturing, Customer Service, and Clinical/Medical Affairs. Support CAPAs, HHEs, NCRs , and other Quality System activities. Meet established complaint investigation timelines, KPIs, and departmental performance expectations. Generate complaint data, metrics, and technical analyses as needed. Maintain knowledge of applicable U.S. and international medical device regulations and guidance. Participate in special engineering, quality, and post-market initiatives. Required Qualifications Bachelor s degree in Engineering from an accredited institution; Biomedical Engineering preferred . 2+ years of experience within a Quality System environment in the medical device, pharmaceutical, or biotechnology industry. Experience with root cause analysis, risk management, engineering problem-solving, and technical report writing. Hands-on experience performing bench/lab testing and documenting work in a clear and traceable manner. Experience using common measurement tools and laboratory instrumentation. Ability to set up experiments, troubleshoot testing issues, and verify data quality. Working knowledge of engineering design principles, CAD, engineering drawings, and GD&T concepts . Experience analyzing investigation data using descriptive statistics, run charts, and basic hypothesis-driven comparisons. Familiarity with FDA Quality Management System requirements (21 CFR Part 820) and/or

ISO 13485

. Strong written and verbal communication skills. Excellent organizational, analytical, and time-management skills. Ability to take ownership of investigations from initial assessment through testing, analysis, conclusions, and documented closure. Ability to work effectively in a fast-paced, highly regulated, cross-functional environment. Preferred Experience Prior experience with one or more of the following is strongly preferred: Medical device complaint handling Post-market surveillance Medical Device Reporting (MDR) Complaint product investigations CAPA and nonconformance investigations Health Hazard Evaluations (HHE) Medical device risk management Ophthalmic devices, implants, or surgical instruments Role Eligibility Candidates must be a U.S. Citizen or U.S. Permanent Resident () . Required training will be completed in accordance with the established training plan for this position.