Senior Design Quality Engineer

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CooperCompanies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Post-IPO Equity on 2021-12

Healthcare • Consulting • Food & Beverage

CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.

📋 Description

• Provide technical leadership for successful Cooper product development and ongoing operational support • Apply design controls, risk management, verification and validation principles, and quality engineering techniques to ensure safe and effective medical devices • Provide expert guidance on scientific and technical data related to products and product testing • Lead teams in identifying and solving complex product problems • Partner with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams • Mentor peers, leads, less experienced DQEs, and cross-functional engineering teams • Represent Quality on product and process development teams • Ensure design control requirements are met for verification, validation, specifications, procedures, risk management, design reviews, and design changes • Own or approve processes within Design Quality • Manage supplier tooling qualification and participate in supplier selection and specification reviews • Define quality characteristics and inspection plans; review and approve PPAP • Lead investigations of complex product problems and manage corrective actions • Evaluate and disposition nonconforming materials and products • Conduct or support health risk assessments for Health Hazard Evaluation, reporting, or recall processes • Participate in design reviews, early product development, physician interactions, product engineering, competitive testing, and prototype testing • Contribute to design and manufacturing documentation and design input requirements • Approve deviations and design changes, conduct impact assessments, and define or approve implementation plans • Develop master test plans and create, evaluate, and validate product and process test methods • Evaluate test protocols and reports for regulatory and quality objectives • Define lifecycle risk management strategies and lead risk management efforts using FMEAs and other tools • Lead strategic initiatives and cross-functional process improvement opportunities • Maintain regulatory knowledge and implement updated standards into procedures • Represent Cooper in FDA, notified body, internal, and other audits • Serve as a technical mentor and recognized subject matter expert in Design Quality Engineering domains • Apply statistical knowledge to evaluate data and provide recommendations • Perform other duties as assigned

🎯 Requirements

• Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and EU MDR • Knowledge of medical device design controls, verification and validation, ISO 14971 risk management, FMEA, and Hazard Analysis • Intermediate proficiency in Excel, Word, and PowerPoint; advanced proficiency preferred • Ability to read and understand highly technical material • Proficiency in reading and writing English • Strong interpersonal, organizational, project management, oral presentation, and technical writing skills • Experience interfacing with senior leadership and external stakeholders • Decision-making, problem-solving, negotiation, and influencing skills • 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 attention to detail • Knowledge of IEC 62304 preferred • Knowledge of one or more of ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 preferred • 10+ years of Quality Engineering experience in the medical device industry with a bachelor’s degree, or 8+ years with a master’s degree • Related engineering experience in R&D or Manufacturing may apply when it includes the listed responsibilities • Hands-on medical device product development experience from concept through commercialization and/or experience leading design changes, improvements, or remediation initiatives in sustaining operations • Knowledge of women’s health is a plus • Thorough knowledge of statistics and its application to data evaluation and recommendations • Ability to comply with applicable FDA and international regulatory laws and standards and Cooper’s Code of Conduct