FiúnEx
Website:
fiunex.com
Job details:
Hiring: R&D Engineer – Medical Device Design & Development | Pune
We are looking for a driven R&D Engineer to join our team and contribute to the design, development, and improvement of medical devices in a regulated environment.
🔹 Key Responsibilities:
• Specs Creation (Design Inputs & Outputs)
• Work on NPD / NPI projects from concept to commercialization
• Handle ECN / ECR and design changes
• Maintain DHR, DMR & PLM documentation
• Perform Verification & Validation (V&V)
• Prepare Test Protocols & Test Reports
• Participate in DQC / DQA reviews
• Support risk management (ISO 14971) and design control activities
• Exposure to 510k submission is a plus
🔹 Required Skills & Experience:
✔ 3+ years in Medical Device R&D
✔ Strong knowledge of Design Control (ISO 13485)
✔ Good understanding of Risk Management (ISO 14971)
✔ Experience in product development & documentation
✔ Strong problem-solving and cross-functional collaboration skills
📍 Location: Pune
⚠️ Only candidates from Medical Device industry must apply
⚡ Immediate joiners only
📩 Share your CV at: mtewari@fiunex.com
Click on Apply to know more.