Manager, Formulation & Development

• 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, R&D) and external testing labs/vendors.

Maintain documentation traceability, design controls, and change-control records within the document management system