Medical Device Project Manager

4 days ago

Warsaw, Indiana, United States TEPHRA Full time

Job Title: Medical Device Project Manager

Job Summary:

We are seeking a highly skilled Medical Device Project Manager to join our team at TEPHRA. The successful candidate will be responsible for managing Medical Device New Product Development projects, ensuring adherence to timelines and business commitments, and managing project risks and contingency plans.

Key Responsibilities:

  • Manage Medical Device New Product Development projects
  • Ensure adherence to timelines and business commitments
  • Manage project risks and develop contingency plans
  • Capture project-specific metrics and present progress reports to Program Management and other stakeholders
  • Monitor overall progress of the project(s) and use of resources, budget, and infrastructure as appropriate
  • Report issues to the Customer and Client management to ensure appropriate closure
  • Manage design History File, Design Control Plan
  • Manage Design Verification and Validation activities
  • Manage Risk Management activities
  • Interact with all functional groups involved in product development process - Manufacturing, Design Quality, Marketing, External Supplier, etc.

Qualifications:

  • Bachelor's Degree in Mechanical Engineering, Bachelor's Degree in Bio-Medical Engineering, or Bachelor of Science with relevant experience
  • At least 3 years relevant experience in Project Management, preferably in Medical Devices/Pharma industries
  • Knowledge of using Project Management and Program Management tools and concepts
  • PMP or equivalent certification is preferable
  • Strong knowledge of New Product Development, preferably in Medical Devices
  • Medical device risk assessment techniques, design failure mode effect analysis (DFMEA)
  • Exposure to Product Development Documentation
  • Some exposure to Design Quality
  • Orthopaedic or Spine Product knowledge will be an advantage
  • Proficient with MS Office applications such as MS Word, PowerPoint, Excel, and MS Project
  • Candidate should possess strong communication and inter-personal skills
  • Conflict management skills and the ability to manage complex cross-functional and cross-cultural teams is a must

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