Date PostedSeptember 10, 2023
Location (State / UT)
Expiration dateAugust 22, 2024
Experience7 Years, 12 Years
Desired QualificationBachelor Degree, Master’s Degree
Roles and Responsibilities:
- Project lead for medical device & development from concept design to product realization.
- Prepare project plan in coordination with cross-functional team and monitor.
- Maintained design history file & define product specifications, and component drawings along with Manufacturing process & work instructions.
Lead design reviews addressing product risk management & Identify the CTQs.
- Coordinate with suppliers for plastic component design, mold development & qualification
- Identify the machine manufacturer & develop the SPM for manufacturing.
- Develop design verification & validation plan as per ISO standards and product specifications.
- Analyse and troubleshoot product issues in a time-bound manner.
- Maintain quality system documents in line with ISO, FDA & EU guidelines.
- Coordinate with the manufacturing site for design transfer
Desired Candidate Profile
- Candidate should have knowledge of device development, CAD, materials, and machines for different design formats.
- Experience in Plastic component design, Mould development and qualification
- Should have prior working experience in a system using FDA GMP requirements noted in 21 CFR 820, especially design controls.
- In-depth knowledge of ISO 13485 Quality System Requirements, Medical Device Directive, and ISO 14971 Risk Management for Medical Devices.
Qualification: B.Tech/B.E. in Mechanical, M.Pharma, M.Tech in Plastics, Mechanical, Ph.D/Doctorate