1. Leadership &

- Strategy

- Lead the design and development function, ensuring alignment with organizational goals, regulatory requirements, and quality standards.

- Provide technical and regulatory guidance to Design Engineers and Quality Engineers.

- Foster innovation while ensuring risk-based design, patient safety, and regulatory compliance.

- Drive continuous improvement in design processes, CAD practices, and risk management methodologies.

2. Design &

- Development Oversight

- Review and approve design inputs, outputs, CAD models, BOMs, and technical documentation.

- Oversee maintenance of Design History Files (DHF), Risk Management Files (RMF), and other regulatory documentation.

- Ensure design control activities are executed effectively across the product lifecycle, from concept to commercialization.

- Guide design transfer activities from R&D; to manufacturing, ensuring manufacturability and robustness.

3. Quality &

- Compliance

- Ensure compliance with global regulations and standards,



including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62366.

- Provide oversight on risk management activities (e.g., FMEA) and design validation/verification processes.

- Manage design-related non-conformances, CAPAs, and engineering change control activities.

- Support internal and external audits, including FDA and ISO inspections, by ensuring design and quality documentation is accurate and audit-ready.

4. Team Management &

- Collaboration

- Supervise, mentor, and develop Design Engineers and Quality Engineers.

- Drive cross-functional collaboration with R&D;, QA, Manufacturing, and Regulatory Affairs.

- Ensure effective communication of design progress, risks, and mitigation strategies to senior leadership.

- Promote a culture of accountability, innovation, and regulatory excellence within the design team.

📌 Lead - Quality Engineering (Knee & Hip Implants) (Rajkot)
🏢 Alkem MedTech Private
📍 Rajkot