Lead Design Quality Engineer

JOB DESCRIPTION Cooper Surgical 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 Cooper Companies, 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

The Lead 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.

The Lead Design Quality Engineer will provide Design Quality Engineering support and leadership to ensure the successful development of Cooper products and ongoing operational support. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to positively influence development efforts as needed. In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.

Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position also coaches, reviews and delegates work to lower level specialists.

• Quality Representation
  • Actively represent Quality function on product/process development teams.
  • Mentor other discipline as needed in the Quality Engineering methodology.
  • Provide guidance to Engineering staff and other personnel and ensures that 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.
  • Participates 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 the Engineering Team.
• CAPAs/Non-conformances
  • Lead or Participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
  • Evaluates and dispositions 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 to 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.
  • Provides 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.
  • Contributes to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
• V&V
  • Participate in the development of the master test plans (I.E. trace matrix, VMP…) that encompass design verification, design validation and process validation activities.
  • Creation,…