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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

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.  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.

Essential Functions & Accountabilities:

• Quality Representation
  • Actively represent Quality function on product/process development teams.
  • Mentor other discipline as need 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, evaluation, and validation of product and process test methods.
  • Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Risk
  • Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
• Process Improvement
  • Actively identifies and leads opportunities for improvements across all cross functional departments. 
  • Promotes continuous improvement in design control activities and use of quality tools with design team and other departments.
• Regulatory
  • Comply with applicable FDA