Product Surveillance Engineer I

About CooperSurgical

JOB DESCRIPTION

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: Trumbull, CT (on-site)

Scope: Post Market Surveillance investigation and root cause analysis.

Job Summary:

The Product Surveillance Engineer is responsible for performing 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.

Responsibilities

• 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 determination.  Test 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

Qualifications

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:

• Bachelor's degree in Engineering or Science required.
  
  
  

Our Benefits:

As an employee of CooperSurgical, you'll 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 www.coopersurgical.com 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 place. 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.