Manager Medical Device Development | Wockhardt | Aurangabad

Job Description

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