A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
09/13/2026 Job Description Job Description Are you an engineer who enjoys solving complex problems, digging into root causes, and turning technical findings into meaningful solutions? This is an exciting opportunity to join an innovative medical device organization focused on intraocular lens (IOL) technology and make an impact on product quality, patient safety, and continuous improvement. As a Post Market Surveillance Engineer , you'll play a hands-on role investigating product complaints and post-market issues involving ophthalmic implants, instruments, and other medical devices. You'll combine engineering expertise, laboratory testing, data analysis, and risk management to understand what happened, why it happened, and how to help prevent it from happening again. The Post Market Surveillance Engineer will: Lead technical complaint investigations, including product analysis, testing, evaluation, and root cause analysis. Perform hands-on bench and laboratory testing, developing or refining test methods and fixtures when needed. Analyze technical data, complaint history, and trends to identify potential product or quality issues. Conduct risk assessments and support CAPAs, HHEs, NCRs, and other quality system activities. Apply engineering problem-solving methodologies to develop clear, evidence-based conclusions. Prepare technical investigation reports, summaries, and customer-facing responses as needed. Collaborate with Engineering, Quality, Regulatory, Manufacturing, Customer Service, and Clinical/Medical Affairs teams. Support complaint metrics, KPIs, regulatory requirements, and timely investigation closure. Stay current with evolving U.S. and international medical device regulations and guidance.
Requirements:
Bachelor's degree in Engineering; Biomedical Engineering is preferred. 0-2+ years of experience in quality systems within the medical device, pharmaceutical, biotech, or similarly regulated industry. Experience with root cause analysis, risk management, and engineering problem-solving. Hands-on experience with bench/lab testing, measurement tools, and laboratory instrumentation. Working knowledge of CAD, engineering drawings, and GD&T. Ability to analyze technical data using tools such as descriptive statistics, run charts, and basic hypothesis-driven comparisons. Strong technical writing, communication, organization, and problem-solving skills. Familiarity with FDA Quality Management System requirements (21 CFR Part 820) and/or
ISO 13485. A
proactive, ownership-driven approach with the ability to manage investigations from testing and analysis through final conclusions.
Why You'll Love This Opportunity:
This is more than a complaint-handling role; you'll have the opportunity to investigate real-world product performance, work hands-on in the lab, collaborate with experienced technical teams, and directly contribute to the quality and safety of ophthalmic medical devices.
