Roles and Responsibilities:
- Lead Design reviews and create project-specific Design Control as needed and review product risk management activities of new products (Medical Devices).
- Develop overall project timelines, detailed product designs, and performance evaluation strategies including verification and validation that integrate steps for discovery, development, and testing.
- Work with the team to prepare product design specifications and validate product designs, identify constraints and provide corrective actions. Provide design solutions to meet cost-effectiveness and on-time deliveries.
- Analyze and troubleshoot product issues in a timely fashion.
- Coordinate, develop, and maintain quality system documents: formatting documents, reviewing documents, assigning approvals, producing effective documents through the Product Lifecycle Management system, and also ensuring all the Device Development documents are in line with ISO, FDA & EU guidelines.
- Demonstrate proposed solutions by developing documentation as well as hardware concepts, hardware selection processes, optimization, etc.
- Provide guidance and instruction to engineering and manufacturing personnel on the quality system/quality assurance/regulatory requirements and documentation.
Desired Candidate Profile
- Candidate should have knowledge of device development, CAD, materials, and machines for different design formats.
- Should have prior working experience in a system using FDA GMP requirements noted in 21 CFR 820, especially design controls.
- In-depth understanding and knowledge of ISO 13485 Quality System Requirements, Medical Device Directive, and ISO 14971 Risk Management for Medical Devices.
- Must be aware of IEC 60601 safety requirements & IEC 62304 medical device Software life
Qualification: B.Tech/B.E. in Mechanical, M.Pharma, M.Tech in Plastics, Mechanical, Ph.D/Doctorate