Product Surveillance Engineer I

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. 

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.

• Leads and drives complex, high‑risk, and high‑visibility product complaint investigations, serving as the technical authority and primary investigator for combination drug‑device products. 
• Applies engineering and scientific judgment to conduct comprehensive, risk‑based investigations, utilizing advanced root cause analysis tools and methodologies to identify systemic, design, process, or supplier‑related contributors. 
• Independently assesses patient safety impact, product performance risk, and regulatory exposure, and determines appropriate escalation pathways including CAPA initiation, Health Hazard Evaluations, trend analyses, and regulatory reporting. 
• Leads investigation documentation and risk assessments to ensure conclusions are data‑driven, scientifically sound, and defensible. 
• Partners with cross‑functional stakeholders to define investigation strategies, drive timely follow‑up actions, and ensure alignment on root causes, corrective actions, and risk mitigation plans. 
• Provides oversight and technical review of assigned complaint investigations, corrective actions, and effectiveness checks to verify that actions adequately address root causes and mitigate risks. 
• Maintains accurate, complete, and traceable post market surveillance records in complaint handling systems; monitors investigation metrics, timelines, and trends, and proactively escalates risks or delays. 
• Serves as a subject matter expert during internal and external audits and regulatory inspections related to complaint handling, post market surveillance, CAPA, and combination product compliance. 
• Evaluates complaint and post market data to identify trends, emerging risks, and systemic issues, and proactively recommends process, product, or system improvements. 
• Contributes to the development, refinement, and implementation of post market surveillance procedures, tools, and training, supporting continuous improvement and inspection readiness. 
• May provide technical guidance to other team members.
• Perform other duties as assigned.

Travel: This position may require 5% domestic and/or international travel.