Senior Design Quality Engineer

Job Description

The Senior Staff Design Quality Engineer (DQE) will be a senior technical individual contributor responsible for ensuring the safety, effectiveness, and compliance of our medical devices throughout the design and development lifecycle. This position will provide advanced expertise in implementing and maintaining robust quality management systems, leading design control and risk management activities across multiple projects, executing and/or defining plans for executing strategic goals established by leadership, and collaborating with internal and external cross‑functional teams to deliver cutting‑edge medical solutions.

This position operates as a recognized subject‑matter expert and technical authority in one or more specified DQE domains, influencing quality practices across projects/programs and leading the execution of strategic initiatives in alignment with organizational quality objectives.

The Senior Staff Design Quality Engineer will provide technical 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 controls, risk management, verification and validation principles and quality engineering techniques to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.

The Senior Staff Design Quality Engineer provides expert guidance on scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position partners cross‑functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams, and provides mentorship (including coaching, reviewing, training, delegating work) to peers, leads less experienced DQEs, and cross‑functional engineering teams.

• Design Quality Leadership
  • Represent the Quality function on product/process development teams.
  • 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.
  • Conduces 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…