Senior Staff Design Quality Engineer

Accountabilities:

• Provide technical leadership for Design Quality Engineering activities throughout the medical device product lifecycle, from concept and development through commercialization and sustaining operations.
• Represent the Quality function on product and process development teams, ensuring quality requirements are integrated effectively into development activities.
• Ensure design control requirements are appropriately implemented, including design verification, validation, specifications, procedures, risk management, design reviews, design changes, and Design History File activities.
• Serve as an independent reviewer during design reviews and conduct Design History File audits when required.
• Own or approve one or more processes within the Design Quality Engineering scope and promote consistent application of quality methodologies.
• Lead or support supplier quality activities, including supplier selection, specification reviews, new tooling qualification, inspection planning, and PPAP review or leadership.
• Work with engineering teams to define quality characteristics and inspection plans for components, subassemblies, and finished medical devices.
• Lead investigations into complex product problems, identify root causes, and manage corrective actions arising from investigations.
• Evaluate and disposition nonconforming materials and products used in pilot and clinical builds.
• Conduct or support health risk assessments related to Health Hazard Evaluations, reporting, and potential product recalls.
• Participate in design reviews and provide quality input on alternative design solutions, product architecture, and manufacturability.
• Contribute hands-on during early product development activities, including physician interactions, product engineering, competitive product testing, and prototype testing.
• Review and provide input to material specifications, drawings, inspection procedures, manufacturing procedures, and other design and manufacturing documentation.
• Approve deviations and design changes, conduct impact assessments, and define or approve appropriate implementation plans.
• Develop and support master test plans covering design verification, design validation, process validation, traceability, and related quality activities.
• Create, evaluate, and validate product and process test methods and review test protocols and reports to ensure regulatory and quality objectives are met.
• Define and maintain risk-management strategies throughout the product lifecycle, including Risk Management Plans, Risk Management Files, and benefit-risk evaluations.
• Lead risk-management activities using FMEA, Hazard Analysis, and other appropriate tools, ensuring risks are effectively identified, controlled, monitored, and incorporated into design improvements.
• Lead strategic quality initiatives and, where appropriate, manage cross-functional teams responsible for delivering improvement plans.
• Identify opportunities for continuous improvement across Quality, Engineering, Manufacturing, and other functions, strengthening design controls, risk management, and quality practices.
• Maintain knowledge of applicable FDA and international regulatory requirements and support implementation of updated standards and procedures.
• Represent the Quality function during regulatory, notified-body, internal, and other audits as required.
• Serve as a technical mentor to Quality Engineers and other team members, providing guidance on complex quality engineering topics and methodologies.
• Act as a recognized subject matter expert in one or more Design Quality Engineering domains across the organization.
• Apply statistical knowledge to analyze technical data, evaluate results, and provide evidence-based recommendations.
• Perform other quality engineering and technical responsibilities as assigned.

Requirements:

• Bachelor’s degree in Engineering or a related technical discipline with 10+ years of Quality Engineering experience in the medical device industry, or a Master’s degree with 8+ years of relevant experience.
• Experience in related engineering areas such as R&D or Manufacturing may be considered when responsibilities include substantial medical device quality engineering work.
• Extensive hands-on experience with medical device product development from concept through commercialization and/or leading design changes, product improvements, remediation, or sustaining initiatives.
• Advanced working knowledge of FDA QMS requirements, including 21 CFR Part 820, as well as ISO 13485 and EU MDR.
• Strong knowledge of medical device design controls, verification and validation principles, and risk management requirements under ISO 14971.
• Demonstrated experience using risk-management tools such as FMEA and Hazard Analysis and integrating risk activities throughout product realization.
• Proven experience with Change Control, Non-conformance, Deviations, Complaints, Health Hazard Evaluations (HHEs), CAPAs, and related quality processes.
• Strong understanding of quality engineering methodologies, statistical analysis, data interpretation, and evidence-based decision-making.
• Experience leading cross-functional teams in a medical device product development environment.
• Strong ability to influence and negotiate without direct authority across Engineering, Quality, Regulatory, Manufacturing, Clinical, Supplier Quality, and senior leadership teams.
• Excellent technical writing, presentation, verbal communication, organizational, and project management skills.
• Ability to read, interpret, and communicate highly technical material effectively.
• Strong analytical and problem-solving capabilities, combined with exceptional attention to detail.
• Proficiency in English, both written and spoken.
• Intermediate proficiency in Microsoft Excel, Word, and PowerPoint; advanced proficiency is preferred.
• Strong self-motivation, accountability, teamwork, and ability to operate effectively in a cross-functional environment.
• 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.
• Experience in women’s health, fertility, or related medical device applications is a plus.
• Ability to interface confidently with senior leadership, external stakeholders, regulatory bodies, and other key partners.

Benefits:

• Remote work: Remote position based in India, with the role associated with the Gurgaon, Haryana location.
• Senior technical ownership: Opportunity to serve as a recognized Design Quality Engineering subject matter expert.
• Professional growth: Significant exposure to advanced medical device quality, regulatory, risk management, verification, validation, and design-control practices.
• Leadership opportunities: Ability to mentor Quality Engineers and lead cross-functional teams and strategic quality initiatives.
• Cross-functional exposure: Collaborate with R&D, Operations, Regulatory, Clinical, Supplier Quality, Manufacturing, and senior leadership teams.
• Product lifecycle exposure: Work across concept development, product testing, commercialization, sustaining engineering, remediation, and design changes.
• Meaningful impact: Direct influence on the safety, effectiveness, quality, and regulatory compliance of medical devices.
• Continuous improvement: Opportunities to shape quality methodologies, strengthen design controls, and improve product-development processes.
• Technical environment: Exposure to internationally recognized medical device standards, regulatory frameworks, risk-management methodologies, and advanced quality tools.
• Full-time schedule: Full-time, day-shift position.