Job Summary

- 5 – 15 years of experience in Health Care products working on the system activities in New Product Development
- Well versed with end-to-end requirements management and traceability & documentation
- Experience in managing Risk Management , FMEA
- Experience in V&V;, Usability Safety, Certification, Service, Tech Pub
- Exposure to design transfer and ECCB process
- Good knowledge of Regulatory, Standards, Safety & Compliance, Compliance testing, CDSCO, MDR, NMPA

Key Responsibilities

- 5 – 15 years of experience in Health Care products working on the system activities in Recent Product Development
- Well versed with end-to-end requirements management and traceability & documentation
- Experience in managing Risk Management , FMEA
- Experience in V&V;, Usability Safety, Certification, Service, Tech Pub
- Exposure to design transfer and ECCB process
- Good knowledge of Regulatory, Standards, Safety & Compliance,



Compliance testing, CDSCO, MDR, NMPA

Skill Requirements

- 5 – 15 years of experience in Health Care products working on the system activities in New Product Development
- Well versed with end-to-end requirements management and traceability & documentation
- Experience in managing Risk Management , FMEA
- Experience in V&V;, Usability Safety, Certification, Service, Tech Pub
- Exposure to design transfer and ECCB process
- Good knowledge of Regulatory, Standards, Safety & Compliance, Compliance testing, CDSCO, MDR, NMPA

Must Have Skill

ReliabIlity Analysis - FMEA,System Requirements Management,Medical Device - Design Risk Management,Medical Device - Medical Device Regulatory Compliance

Good to Have Skill

Other Requirements

📌 Design Lead (Bengaluru)
🏢 HCLTech
📍 Bengaluru