Senior Staff Design Quality Engineer

Job description

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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Staff Design Quality Engineer based in India. This role provides senior technical leadership in design quality for the development and commercialization of medical devices.You will apply expertise in design controls, risk management, verification and validation, and quality engineering to support safe and effective products.The position spans the full product lifecycle, from early concept and design reviews through testing, commercialization, sustaining activities, and design changes.You will work closely with R&D, Operations, Regulatory, Supplier Quality, Clinical, and other cross-functional teams to solve complex product and quality challenges.Your expertise will directly influence product safety, regulatory compliance, manufacturing readiness, and customer outcomes.The role also offers significant opportunities to lead strategic initiatives, mentor quality engineers, and serve as a recognized subject matter expert.This is an ideal opportunity for an experienced medical-device quality professional who combines technical depth with strong leadership, communication, and problem-solving skills.