- Author and maintain Design History File (DHF) documentation, including user needs, design inputs/outputs, and verification validation records.
- Prepare and review QMS documents - SOPs, work instructions, technical reports, and change controls - in line with ISO 13485 and applicable regulations.
- Draft development reports, design verification/validation reports, and human factors (formative summative) reports supporting device safety and usability.
- Support risk management activities (dFMEA / pFMEA, hazard analysis, risk management file per ISO 14971).
- Contribute to design verification/validation testing and test-method/protocol development for device functional performance (e.g., dose accuracy, injection time, force testing).
- Support regulatory submissions and interface with cross-functional teams (Quality, Regulatory, RD) and external testing labs/vendors.
Maintain documentation traceability, design controls, and change-control records within the document management system
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