Product Surveillance Engineer I at CooperCompanies

North Tonawanda, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Jul, 26

Salary

80000.0

Posted On

30 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Post market surveillance, Complaint handling, Risk management, Root cause analysis, Regulatory compliance, Quality management systems, FDA regulations, ISO 13485, Combination products, Medical device engineering, CAPA, Health hazard evaluation, Technical documentation, Regulatory inspections, Data analysis, Cross-functional collaboration

Industry

Medical Equipment Manufacturing

Description

About CooperSurgical 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 [http://www.coopersurgical.com]. Work location: North Tonawanda, NY; Trumbull, CT; or Livingston, NJ (on-site) Scope: The Product Surveillance Engineer I is responsible for 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. This role provides 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, and is a key technical contributor and decision-maker, independently evaluating risk, guiding cross‑functional investigations, and recommending appropriate escalation and remediation strategies. This role helps ensure inspection‑ready documentation, supports regulatory interactions, and contributes strategically to continuous improvement of post market surveillance and Quality Management System (QMS) processes. Job Summary: The Product Surveillance Engineer I is responsible for 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. The role partners 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, and also plays a critical role in supporting audits and regulatory inspections and in advancing post market surveillance capabilities through process optimization, trend evaluation, and alignment with evolving regulatory expectations.

Responsibilities

The Product Surveillance Engineer I leads end-to-end complex product complaint investigations and post-market surveillance evaluations for combination drug-device products. This role drives cross-functional root cause analysis and ensures compliance with regulatory standards through risk management and effective corrective actions.