Manager Medical Device Development | Wockhardt | Aurangabad

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Job Overview

  • Date Posted
    September 10, 2023
  • Location (State / UT)
  • Expiration date
    August 22, 2024
  • Experience
    7 Years, 12 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree

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