CooperSurgical · 8 hours ago
Product Surveillance Engineer I
Trumbull, CT
Full-time
Onsite
Entry Level
1+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients through critical healthcare moments. The Product Surveillance Engineer is responsible for performing root cause analysis on medical devices and IVF customer returns, ensuring quality and compliance with safety standards while collaborating with various internal teams.
Health CareMedical DeviceWomen's
Responsibilities
Test and thoroughly evaluate clinically applied medical devices and IVF products of various degrees of complexity to determine root cause analysis within a closely monitored timeframe
Identify the appropriate test method/regiment/tools from existing Standard Operating Procedures for complaint sample evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination. Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards. Evaluate and review repair logs and field service reports to determine root cause of alleged complaint conditions
Replicate reported failure mode with bench top simulation test methods and document observations accordingly with returned product or similar product as necessary
Collaborate with the Quality Engineering and R&D groups on investigation activities as required and driven by complaint investigation outcomes
Prepare technical investigation reports based on results of evaluation and/or review of the service and repair activities and/or investigation of the alleged product failure
Provide detailed investigation results for customer letters
Participate in weekly team investigation reviews, investigation status meetings, and displays team problem solving/communication skills
Review and close complaint files after reviewing for accuracy, compliance to Departmental Standard Operating Procedures, and Regulatory compliance/audit readiness
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Engineering or Science required
Critical independent thinking, time management, and timely follow up
Ability to work independently as well as in a team setting
Ability to analyze and process data and draw appropriate conclusions
Excellent interpersonal, organizational, and project management skills with the ability to prioritize job functions with attention to detail
Excellent verbal, written, and presentation skills in English with an emphasis on technical writing
Strong operating knowledge of MS Office suite (Outlook, Word, & Excel)
Certification with OSHA BloodBorne Pathogens Standard 29 CFR 1910.1030
Preferred
Quality or compliance experience is preferred with familiarity with root cause investigation tools and techniques
Working knowledge of Master Control and/or IQVIA preferred
1+ year relevant experience (quality or compliance experience preferred with familiarity with root cause investigation tools & techniques)
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal
Sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
2026-01-14
MarketScreener
2025-08-29
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