Senior Design Quality Engineer

This is a fully remote position, open to applicants in India.

📋 Description

• Provide technical leadership to ensure successful development and ongoing operational support of Cooper products.

• Implement design controls, risk management, verification and validation principles, and quality engineering techniques to guarantee the safety and efficacy of medical devices.

• Offer expert advice on scientific and technical data concerning products and their testing.

• Lead teams in diagnosing and resolving intricate product issues.

• Collaborate with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams.

• Mentor peers, team leads, junior DQEs, and cross-functional engineering teams.

• Represent the Quality department in product and process development teams.

• Ensure compliance with design control requirements for verification, validation, specifications, procedures, risk management, design reviews, and design modifications.

• Own or approve processes within the Design Quality framework.

• Manage supplier tooling qualification and engage in supplier selection and specification evaluations.

• Define quality characteristics and inspection plans; review and authorize PPAP.

• Lead investigations into complex product issues and oversee corrective actions.

• Assess and disposition nonconforming materials and products.

• Conduct or assist with 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 as well as design input requirements.

• Approve deviations and design changes, perform impact assessments, and define or endorse implementation plans.

• Develop master test plans and create, assess, and validate product and process testing methodologies.

• Evaluate test protocols and reports to meet regulatory and quality objectives.

• Establish lifecycle risk management strategies and lead risk management initiatives using FMEAs and other methodologies.

• Drive strategic initiatives and cross-functional process enhancement opportunities.

• Maintain knowledge of regulatory standards and incorporate updates into procedures.

• Represent Cooper during FDA, notified body, internal, and other audits.

• Act as a technical mentor and acknowledged subject matter expert in Design Quality Engineering disciplines.

• Utilize statistical expertise to analyze data and provide insights.

• Perform additional duties as assigned.

⛳️ Requirements

• Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and EU MDR.

• Familiarity with medical device design controls, verification and validation, ISO 14971 risk management, FMEA, and Hazard Analysis.

• Intermediate skills in Excel, Word, and PowerPoint; advanced skills preferred.

• Capability to read and comprehend highly technical materials.

• Proficiency in written and spoken English.

• Strong interpersonal, organizational, project management, oral presentation, and technical writing abilities.

• Experience in interfacing with senior leadership and external stakeholders.

• Skills in decision-making, problem-solving, negotiation, and influencing.

• Proven track record in leading cross-functional teams within a medical device development context.

• Familiarity with Change Control, Non-conformance, Deviation, Complaints, HHEs, and/or CAPAs.

• Strong analytical and problem-solving capabilities with a keen attention to detail.

• Knowledge of IEC 62304 is preferred.

• Familiarity with one or more of ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 is preferred.

• 10+ years of Quality Engineering experience in the medical device sector with a bachelor’s degree, or 8+ years with a master’s degree.

• Related engineering experience in R&D or Manufacturing may be considered when it encompasses the listed responsibilities.

• Hands-on experience in medical device product development from concept to commercialization and/or experience in leading design changes, enhancements, or remediation efforts in sustaining operations.

• Knowledge of women’s health is a plus.

• Comprehensive understanding of statistics and its application in data evaluation and recommendations.

• Ability to adhere to relevant FDA and international regulatory laws and standards, as well as Cooper’s Code of Conduct.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous retirement plan options.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to promote work-life balance.