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Sr. Project Manager - Medical Devices

Company: Job Juncture
Location: Cincinnati
Posted on: September 14, 2019

Job Description:

Highly regarded and rapidly growing medical devices company is searching for a Sr. Project Manager to lead a multidisciplinary team in the production of Class II and Class III medical devices. The Sr. Project Manager will:



  • Assume full leadership of cross functional project team that includes cross-marketing, service, manufacturing, quality, legal and regulatory.

  • Be responsible for completion of required elements of the project strategy.

  • Leads engineering team members including mechanical, electrical, software
  • Defines product requirements and design input specification
  • Supervises design verification studies and product validation
  • Develops and manages project budget
  • Manage risk activities including developing risk management plan, coordinating risk analysis and FMEAs


    Requirements:



    • Bachelor's degree in engineering, MS in electronics engineering
    • A depth of experience with imbedded systems
    • 10+ years progressive experience in medical device product development
    • Experience creating and maintaining Design History File (DHF) following 21 CFR Part 820) or ISO 13485 design controls.
    • Knowledge of EN60601-1 and ISO14971 standards
    • Experience moving a product from development into manufacturing
    • Strong project management skills with experience that includes concept through launch
    • Field experience of clinical environment and imaging procedures preferred
    • A track record of managing projects that include multiple competing elements
    • Excellent team leadership and development skills and the ability to work with team members at all levels
    • Strong statistical and analytical skills
    • Experience with IP assessment and FTO studies.

Keywords: Job Juncture, Cincinnati , Sr. Project Manager - Medical Devices, Executive , Cincinnati, Ohio

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