Senior Design Quality Engineer

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 or Livingston, NJ (on-site)

Scope: 

The Senior Design Quality Engineer will be a key leader in ensuring the safety, effectiveness, and compliance of our medical devices throughout the design and development lifecycle. This position will play a critical role in implementing and maintaining robust quality management systems, leading design control activities, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.

Job Summary:

The Senior Design Quality Engineer will provide Design Quality Engineering support and leadership to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to positively influence development efforts as needed and ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.  The Senior Design Quality Engineer also reviews and evaluates scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position may also guide, coach, review and delegate work to lower-level specialists.

• Quality Representation
  • Actively represent Quality function on product/process development teams.
  • Mentor other disciplines as needed in the Quality Engineering methodology.
  • Provide guidance to Engineering staff and other personnel ensuring design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
• Supplier Engagement
  • Manage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool. 
  • Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with Engineering Team.
• CAPAs/Non conformances
  • Lead or participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
  • Evaluate and disposition nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.
• Design 
  • Participate in design reviews to evaluate designs and help identify alternative design solutions.
  • Hands-on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.
  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Contribute to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
• V&V