Bio Medical Engineer Job in For a Client of TeamLease Digital at Pune

Job Requirements and Responsibilities
Section Details / Example Content
Job Requirements* 1. Experience in Medical device product development (preferably orthopedics)

2.Experience in concept development, selection etc.

3. Experience in Risk Management, Design Control, FMEAs, Requirement Traceability Matrix etc.

3. Experience in writing test protocol, verification and validation protocols and reports

6. Experience in Design History File creation

7. Experience in Engineering Change Management, BOM, DMR
Key Responsibilities* 1. Create and maintain project documentation including Design History Files (DHF), Requirement Traceability Matrices (RTM), risk management files, and design verification records.
2. Participate in concept generation, design evaluation, prototyping, and design optimization activities to support new product development initiatives.
3. Collaborate with cross-functional team for alignment, risk mitigation, decision making etc.
4. Support product changes through established Change Management processes, ensuring proper documentation and regulatory compliance.

Job Qualifications & Skills
Section Details / Example Content
Domain Experience in medical device product development and knowledge of FDA/ISO 13485 regulated environments.
Soft Skills - Excellent communication
- Team collaboration
- Documentation and knowledge sharing
Education Requirements Mechanical Engineering, Biomedical Engineering, or related discipline