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 current 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 Engineering

- 3+ 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

- Robust analytical, communication, and problem-solving skills

- Proficiency with PC-based tools and quality documentation systems

📌 Mechanical Quality / Design Control Engineer (Pune)
🏢 Cyient
📍 Pune