Product Surveillance Engineer I

CooperCompanies•North Tonawanda, NY

16h•Onsite

About The Position

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Requirements

Technical and regulatory expertise in the evaluation of product complaints, post market signals, and emerging risks.
Ability to ensure product safety, performance, quality, and compliance throughout the product lifecycle.
Ability to independently evaluate risk.
Ability to guide cross‑functional investigations.
Ability to recommend appropriate escalation and remediation strategies.
Ability to ensure inspection‑ready documentation.
Ability to support regulatory interactions.
Ability to contribute strategically to continuous improvement of post market surveillance and QMS processes.
Sound engineering judgment.
Risk management principles.
Regulatory knowledge.
Ability to assess product performance, patient safety impact, and compliance risk.
Ability to determine appropriate escalations such as CAPA initiation, Health Hazard Evaluations (HHEs), trending, and regulatory reporting.
Ability to partner closely with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, and Supply Chain.
Ability to drive robust root cause analysis.
Ability to influence cross‑functional decision‑making.
Ability to ensure timely and effective corrective actions.
Ability to support audits and regulatory inspections.
Ability to advance post market surveillance capabilities through process optimization, trend evaluation, and alignment with evolving regulatory expectations.

Responsibilities

Leading, assessing, and driving post market surveillance activities for combination drug‑device products in compliance with applicable U.S. and international regulations, including 21 CFR Parts 210, 211, 820, and ISO 13485.
Providing technical and regulatory expertise in the evaluation of product complaints, post market signals, and emerging risks to ensure product safety, performance, quality, and compliance throughout the product lifecycle.
Independently evaluating risk, guiding cross‑functional investigations, and recommending appropriate escalation and remediation strategies.
Ensuring inspection‑ready documentation.
Supporting regulatory interactions.
Contributing strategically to continuous improvement of post market surveillance and Quality Management System (QMS) processes.
Leading the end‑to‑end leadership of complex product complaint investigations and post market surveillance evaluations for combination drug‑device products.
Applying sound engineering judgment, risk management principles, and regulatory knowledge to assess product performance, patient safety impact, and compliance risk to determine appropriate escalations such as CAPA initiation, Health Hazard Evaluations (HHEs), trending, and regulatory reporting.
Partnering closely with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, and Supply Chain to drive robust root cause analysis, influence cross‑functional decision‑making, and ensure timely and effective corrective actions.
Supporting audits and regulatory inspections.
Advancing post market surveillance capabilities through process optimization, trend evaluation, and alignment with evolving regulatory expectations.