Product Surveillance Engineer I

CooperCompanies•North Tonawanda, NY

21h•Onsite

About The Position

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. 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.

Requirements

Strong working knowledge of FDA and international regulations governing combination products, including 21 CFR Parts 211 and 820, ISO 13485, and post market surveillance expectations
Demonstrated experience leading complex, risk‑based investigations and applying advanced root cause analysis techniques to support robust conclusions and escalation decisions.
Deep understanding of risk management principles and the ability to independently evaluate patient safety, product performance, and regulatory compliance implications.
Proven ability to author and defend high‑quality, inspection‑ready documentation that withstands internal and external audit scrutiny.
Strong written and verbal communication skills, including the ability to influence and align cross‑functional stakeholders and present investigation outcomes to leadership.
Excellent analytical, problem‑solving, and decision‑making skills with the ability to operate with minimal supervision.
Highly organized with the ability to manage multiple, concurrent investigations and priorities while meeting regulatory and business timelines.
Demonstrated experience supporting or leading regulatory inspections and audits related to complaint handling, post market surveillance, and CAPA processes.
Ability to function as a technical and trusted advisor within cross‑functional quality and regulatory teams.
2+ years of experience working in manufacturing environment preferably within pharmaceutical or medical device related field.
2+ years of progressive experience in product complaint handling, post market surveillance, quality engineering, or related quality systems within a regulated pharmaceutical, medical device, or combination product environment.

Nice To Haves

Bachelor’s degree in a Health, Engineering or Science field preferred.

Responsibilities

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.