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: 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.