Senior 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.

Essential Functions & Accountabilities:

• Design Quality Leadership
  • Represent the Quality function on product/process development teams.
  • Act as the subject matter expert for Design Quality in the domain of sterile product development.
  • Mentor other discipline as needed in the Quality Engineering methodology.
  • Ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, design reviews, and design changes. May serve as independent reviewer during design reviews, or conduct DHF audits, as required.
  • Owner/Approver of one or more processes within the scope of Design Quality.
• Supplier Engagement
  • Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper's specifications.
  • Manage supplier to ensure all quality and manufacturing elements supporting final components are qualified at the supplier and on time utilizing PPAP tool.
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.
  • Review/Approval of PPAP. May serve as PPAP lead.
• CAPAs/Non conformances/HHE
  • 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.
  • Conducts or supports health risk assessments in support of the Health Hazard Evaluation, Reporting or Recall processes.
• Design
  • Participate in design reviews to evaluate designs, ensure DHF completeness and accuracy, 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 as a result of risk analysis, from experience with previously reported problems, Cooper's products, competitive devices and/or other similar products.
  • Approves deviations and design changes, conducts impact assessments, and defines/approves change implementation plans.
• Verification & Validation
  • 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, evaluation, and validation of product and process test methods.
  • Apply statistical techniques in sample size determination and data analysis.
  • Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Risk Management
  • Defines risk management strategy throughout product lifecycle including construction of the Risk Management File, Risk Management Planning, and benefit-risk evaluations.
  • Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools, ensuring effective integration of risk activities throughout product realization process and…