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.