DHF Engineer - Immediate joiners For Pune location

Job description

**Job Title:** DHF Author / Reviewer / SME **Role Purpose** Develop, review, and maintain Design History File (DHF) documentation for tubing systems and electromechanical devices. Ensure compliance with **ISO 13485**, **21 CFR 820**, and **ISO 14971** through robust design controls, risk management, and traceability. **Key Responsibilities** - **Design Controls** - Author and review DHF elements: **User Needs**, **Design Inputs/Outputs**, **Design Reviews**, **Verification & Validation (V&V) plans**. - Maintain **traceability matrix** linking requirements to risk and V&V. - **Risk Management** - Develop and review **Risk Management Files** per **ISO 14971**. - Perform **hazard analysis**, **FMEA**, and risk-benefit assessments. - **Usability & Human Factors** - Incorporate usability engineering principles into design documentation. - **Compliance & Standards** - Ensure adherence to **ISO 13485**, **21 CFR 820**, and applicable IEC standards. - **Tools & Documentation** - Use **Vault**, Doors and **Polarion** for document control and requirements management. - Maintain audit-ready documentation and version control. **Required Skills & Qualifications** - Bachelor’s degree in Engineering, Biomedical, or related field. - **6 - 8 years** experience in DHF documentation and design controls. - Strong knowledge of: - **ISO 13485**, **21 CFR 820**. - **ISO 14971** risk management, hazard analysis, FMEA. - Experience with **traceability**, **V&V planning**, usability documentation. **Preferred** - Experience with tubing systems and electromechanical devices. - Familiarity with IEC 60601 series and usability standards (IEC 62366-1). - Strong technical writing and cross-functional collaboration skills.