Mechanical Quality / Design Control Engineer, Pune

Experience: 5-10 years / Band C Key Responsibilities Design Control&Documentation (NPD): Drive completion of Design History Files (DHF) from user needs to design outputs, ensuring compliance for new orthopedic product introductions. Verification&Validation (V&V): Lead test protocol development and execution for biomechanical, sterilization, and material validation to confirm product performance. Risk Management: Maintain the Risk Management File (ISO 14971), conducting FMEA and clinical risk assessments across the product lifecycle. Life Cycle Management (LCM): Oversee sustaining engineering activities, including product modifications, line extensions, and engineering change requests (ECR/ECO).Design Transfer: Collaborate with Manufacturing and Operations to ensure smooth, compliant transfer of designs into production. Regulatory Support: Provide documentation for audits and regulatory submissions (FDA 510k, EU MDR) and participate in design reviews. Process Improvement: Apply Lean and Six Sigma tools to improve design control processes, reduce defects, and enhance efficiency.Quality&Field Support: Conduct field inspections, calibration, PFMEA, and maintain field quality procedures/work instructions. CAPA&Non‑Conformance: Support corrective/preventive actions, quality holds, and resolution of non‑conformances. Inspection&Testing: Perform verification of finished goods, purchased products, and raw materials; conduct visual/dimensional inspections per GMP requirements. Root Cause Analysis: Investigate issues, recommend corrective actions, and ensure preventive measures are implemented. Training&Mentorship: Train team members on inspection methods, equipment use, and quality systems. Cross‑Functional Collaboration: Partner with Quality Managers, Field Offices, Commercial Operations, and Distribution teams to support projects and quality initiatives. Required Qualifications Bachelor's degree in Mechanical, Biomedical, Manufacturing, or Industrial Engineering3+ years of quality or manufacturing engineering experience Working knowledge of FDA QSR, ISO 13485, and ISO 14971 Experience with inspections, technical drawings, and measurement equipment Strong analytical, communication, and problem-solving skills Proficiency with PC-based tools and quality documentation systems