Staff Design Quality Engineer

About the role

The Staff Design Quality Engineer is an experienced technical individual contributor responsible for ensuring the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle.

Responsibilities

• Represent the Quality function on product/process development teams. Mentor other disciplines 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. Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team. Lead and actively support supplier quality activities, including close collaboration with external suppliers to ensure components, assemblies, and processes meet design specifications, quality requirements, and applicable regulatory standards.
• Ensure that supplier-provided PPAP and qualification documentation is complete, accurate, and aligned with design intent, risk management outputs, and validation requirements.
• Partner with Supply Chain, Engineering, Manufacturing, and Regulatory teams to ensure suppliers are properly qualified and able to consistently deliver production-representative components suitable for clinical and commercial use.
• Assess supplier readiness and performance through technical reviews, audits, and data analysis, identifying gaps and driving corrective actions as needed to mitigate quality and compliance risks.
• Act as a key quality decision-maker, providing clear recommendations based on technical data, supplier capability, and regulatory expectations to support safe, effective, and compliant products.
• Evaluates and disposes of nonconforming materials and products used in pilot and clinical builds.
• 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. 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.
• Approves deviations and design changes, conducts impact assessments, and defines/approves 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. 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 feedback into design improvements and maintenance of the product risk profile. 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 and Project Management: Actively identifies and leads opportunities for improvements across all cross-functional departments. Promotes continuous improvement in design control and risk management activities and use of quality tools with design team and other departments.
• Regulatory: Comply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct. Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. Implement new or updated standards into existing procedures. Represent Cooper as needed in FDA, notified body, internal, and other audits.
• Technical Mentorship: Serve as a technical mentor to QEs, providing guidance on complex quality engineering topics. Promote continuous improvement and consistent application of design quality tools and methodologies. Thorough knowledge of statistics and how to apply, evaluate, and provide recommendation from the data.
• Perform other duties as assigned.

Qualifications

• Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR.
• Demonstrated knowledge in the application of medical device design controls, verification/validation, risk management principles per ISO 14971 , and the use of risk assessment tools such as FMEA, Hazard Analysis.
• Intermediate skill in the use of Excel, Word and PowerPoint.
• Knowledge in Knowledge in application of IEC 62304 preferred.
• Knowledge in one or more ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 preferred.
• 7+ years or more experience in Quality Engineering in the medical device industry.
• Experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
• Hands-on experience in medical device product development in concept through commercialization, and/or leading design changes, improvements or remediation initiatives in sustaining operations.
• Knowledge in women’s health a plus.
• Bachelor’s Degree or higher in Science or Engineering (or related field).
• Certification in Quality Engineering (ASQ Certified Quality Engineer).

Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.