Senior R&D Engineer

Responsibilities :

• Prepare and present structured technical documentation and summaries for internal and external stakeholders.
• Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs / Outputs, DV protocols, test cases, and reports.
• Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software).
• Manage and maintain the Input / Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities.
• Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment.
• Participate in and / or lead formal design reviews, risk reviews, and test planning sessions.
• Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations.
• Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971.

Requirements :