Staff Design Quality Engineer

CooperCompanies•Trumbull, CT

5d•Onsite

About The Position

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. This position provides technical expertise in implementing and maintaining quality management system requirements, leading design control and risk management activities for product development projects, and supporting the execution of quality and business objectives established by leadership. The Staff DQE collaborates with internal and external cross-functional teams to deliver high-quality medical device solutions that meet regulatory, customer, and business requirements. This position serves as a key quality representative on product development and sustaining engineering projects, providing guidance on quality engineering principles, design controls, risk management, verification and validation activities, and supplier quality processes. The Staff DQE influences project-level quality decisions, drives compliance to applicable standards and regulations, and supports continuous improvement initiatives within the organization. The Staff Design Quality Engineer provides technical leadership and quality engineering support to ensure the successful development, transfer, and ongoing support of Cooper products. This individual applies knowledge of design controls, risk management, verification and validation principles, quality engineering techniques, and supplier quality processes, including supplier collaboration and PPAP execution, to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations. The Staff Design Quality Engineer provides guidance on scientific and technical data related to product design, manufacturing processes, and product testing to support quality and compliance objectives. This position partners cross-functionally with R&D, Operations, Regulatory, Supplier Quality and Clinical teams. The Staff DQE provides guidance and knowledge sharing to peers and less experienced engineers, contributes to problem-solving activities and continuous improvement efforts, and supports the successful execution of product development and sustaining engineering programs.

Requirements

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. Advanced preferred.
Ability to read and understand highly technical material.
Proficient in reading and writing in English
Self-motivated and committed to a team approach
Strong interpersonal, organizational and project management skills.
Ability and experience interfacing with senior leadership and external stakeholders.
Strong oral, presentation and technical writing skills
Demonstrated skills in decision making, problem solving, negotiation, and influencing without direct authority preferably across a broad spectrum of Quality Engineering responsibilities
Proven experience leading cross-functional teams in a medical device development environment.
Experience with Change Control, Non-conformance, Deviation, Complaints, HHEs and/or CAPAs.
Strong analytical and problem-solving skills with acute attention to detail.
Excellent communication and interpersonal skills.
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.

Nice To Haves

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.
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)

Responsibilities

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.
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.
Demonstrate strong working knowledge and hands‑on experience with Production Part Approval Process (PPAP) execution, including review and approval of supplier deliverables such as PFMEAs, control plans, process flow diagrams, capability studies, and dimensional layouts
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.
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.
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.
Approves deviations and design changes, conducts impact assessments, and defines/approves implementation plans.
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.
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.
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.
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.
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.