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: Trumbull CT (on-site)

Scope:Post Market Surveillance investigation and root cause analysis.

Job Summary:

The Product Surveillance Engineer is responsible forperforming root cause analysis on clinically applied medical device and invitro fertilization (IVF) global customer returns to ensure high levels of quality reliability safety and efficacy. This role will collaborate as needed with internal Quality Service Engineering Manufacturing and Research & Development (R&D) teams while assisting management with continuous improvement and maintaining complaint handling processes and activities utilizing six sigma and lean processes as well as maintaining compliance with global medical device regulations and safety standards.

• Test and thoroughly evaluate clinically applied medical devices and IVF products of various degrees of complexity to determine root cause analysis within a closely monitored timeframe.

• Identify the appropriate test method/regiment/tools from existing Standard Operating Procedures for complaint sample evaluation execute the method and interpret the data (technical) for definitive root cause analysis methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards. Evaluate and review repair logs and field service reports to determine root cause of alleged complaint conditions.

• Replicate reported failure mode with bench top simulation test methods and document observations accordingly with returned product or similar product as necessary.

• Collaborate with the Quality Engineering and R&D groups on investigation activities as required and driven by complaint investigation outcomes.

• Prepare technical investigation reports based on results of evaluation and/or review of the service and repair activities and/or investigation of the alleged product failure.

• Provide detailed investigation results for customer letters.

• Participate in weekly team investigation reviews investigation status meetings and displays team problem solving/communication skills.

• Review and close complaint files after reviewing for accuracy compliance to Departmental Standard Operating Procedures and Regulatory compliance/audit readiness.

• Perform other duties as assigned.

Travel: n/a

Knowledge Skills and Abilities:

Critical independent thinking time management and timely follow up.
Ability to work independently as well as in a team setting.
Quality or compliance experience is preferred with familiarity with root cause investigation tools and techniques.
Ability to analyze and process data and draw appropriate conclusions.
Excellent interpersonal organizational and project management skills with the ability to prioritize job functions with attention to detail.
Excellent verbal written and presentation skills in English with an emphasis on technical writing.
Strong operating knowledge of MS Office suite (Outlook Word & Excel).
Working knowledge of Master Control and/or IQVIA preferred.
Certification with OSHA BloodBorne Pathogens Standard 29 CFR 1910.1030.

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:

1 year relevant experience (quality or compliance experience preferred with familiarity with root cause investigation tools & techniques).

Education:

Bachelors degree in Engineering or Science required.

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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 at to 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.