About the Role
We are looking for a Design Assurance & RA Engineer to sit at the intersection of product development and regulatory compliance : embedded with the Design & Development (D&D) team, driving design controls and regulatory readiness for our active product programs.
Roles & Responsibilities
Design Controls & D&D Interface
- Own and maintain the Design History File (DHF) and Design Traceability Matrix
- Participate in design reviews, design input/output reviews, and cross-functional milestone meetings with the D&D team
- Identify regulatory and safety requirements per product and translate them into actionable engineering guidance for the D&D team
- Review engineering drawings, specifications, and design documentation for regulatory compliance
- Support preparation and execution of V&V protocols and reports
- Lead risk management activities per ISO 14971 throughout the product design lifecycle
- Develop and maintain the Risk Management File — Hazard Analysis, Design/Process FMEA, Risk-Benefit Analysis
- Verify implementation of risk controls at design level and document residual risk acceptability
- Identify and map applicable standards per product.
- Help RA team in preparing Regulatory Dossiers for regulatory submissions
- Prepare all product-level regulatory and design assurance documents to submission quality — traceable, complete, and standard-compliant
- Coordinate with D&D team to gather required technical data for document preparation
Required Qualifications
Education: B.E. / B.Tech in Biomedical Engineering, Mechanical Engineering, Electronics Engineering.
Experience: 2–3 years in a medical device company in Design Assurance & Regulatory Affairs.
Must-Have Experience:
- Hands-on experience with design controls and DHF management per ISO 13485
- Practical knowledge of ISO 14971 — has prepared or contributed to a Risk Management File
- Knowledge of IEC 60601-1, MDR 2017.
- Strong technical writing and cross-functional communication skills
- Prior experience interfacing directly with engineering / D&D teams as a quality or regulatory representative
- Certified/Training on IEC 60601-1, ISO 14971, Design Quality Engineering Course
Preferred:
- Background in surgical, electromechanical, capital equipment, or robotic devices
- IEC 62366-1 (usability) and IEC 60601-1-2 (EMC) documentation exposure
- Exposure to CE marking process or EU MDR
