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Senior Project Manager - Medical Devices

Posted on Sep 12, 2019 by Job Juncture

Cincinnati, OH 45201
Health Care
Immediate Start
Annual Salary
Full-Time
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.

Reference: 755523860

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