Position: Design History File (DHF) Executive / Engineer
Location : Talegaon Dabhade (Pune)
Qualification: Diploma / Graduate in Engineering (Mechanical, Biomedical, or Relevant Technical Field)
Experience: 1–3 Years (Preferred: Medical Device Industry)
Salary: As per Interview Performance
Job Responsibilities
- Develop and maintain comprehensive Design Control documentation to ensure compliance with Quality Management System (QMS) requirements and applicable regulatory standards throughout the product lifecycle.
- Prepare, review, and maintain Design History Files (DHF) for medical devices.
- Maintain and update Design Input and Design Output documentation.
- Prepare and manage Risk Management Files including:
- Design Failure Mode and Effects Analysis (DFMEA)
- Use Failure Mode and Effects Analysis (UFMEA)
- Hazard Analysis
- Risk Management Reports
- Conduct and maintain Comparative Threshold Analysis documentation.
- Support Design Verification and Validation (V&V) activities and related documentation.
- Prepare and maintain General Safety and Performance Requirements (GSPR) documentation.
- Assist in the preparation and maintenance of Clinical Evaluation Reports (CER).
- Prepare and maintain Declarations of Conformity (DoC).
- Ensure all design and development documents are current, controlled, and audit-ready.
- Coordinate with R&D, Regulatory Affairs, Quality Assurance, and Manufacturing teams for documentation updates and compliance activities.
- Support internal, external, and regulatory audits related to design control documentation.
Required Skills
- Knowledge of Medical Device Design Control requirements.
- Understanding of ISO 13485, MDR 2017/745, and Risk Management as per ISO 14971.
- Good documentation and technical writing skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Attention to detail and strong organizational skills.
- Ability to work independently and within cross-functional teams.
