Product Surveillance Engineer I

About CooperSurgical

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

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 drugdevice products in compliance with applicable U.S. and international regulations including 21 CFR Partsand 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 crossfunctional investigations and recommending appropriate escalation and remediation strategies. This role helps ensure inspectionready 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 endtoend leadership of complex product complaint investigations and post market surveillance evaluations for combination drugdevice 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 crossfunctional decisionmaking 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 highrisk and highvisibility product complaint investigations serving as the technical authority and primary investigator for combination drugdevice products.
• Applies engineering and scientific judgment to conduct comprehensive riskbased investigations utilizing advanced root cause analysis tools and methodologies to identify systemic design process or supplierrelated 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 datadriven scientifically sound and defensible.
• Partners with crossfunctional stakeholders to define investigation strategies drive timely followup 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.

Knowledge Skills and Abilities:

• 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 riskbased 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 highquality inspectionready documentation that withstands internal and external audit scrutiny.
• Strong written and verbal communication skills including the ability to influence and align crossfunctional stakeholders and present investigation outcomes to leadership.
• Excellent analytical problemsolving and decisionmaking 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 crossfunctional quality and regulatory teams.

Work Environment:

• Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting standing or getting up and down throughout the day.
• Occasionally lift to 35 pounds.

Experience:

• 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.

Education:

• Bachelors degree in a Health Engineering or Science field preferred.

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Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between$60000.00 - $80000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.