Senior Project Manager - Medical Devices
Posted on Sep 12, 2019 by Job Juncture
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
- 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.