Risk Manager
Details: Job Description
Stefanini Group is hiring! Exciting opportunity awaits, let us help you get started! Click Apply now or you may call Ghanshyam Sharma at 248 263-5646 or email at Ghanshyam.Sharma@stefanini.com for faster processing! The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and updates.
Essential Duties & Responsibilities:
- Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.).
- Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs.
- Demonstrated understanding of operational, functional & physical architectures & their use for analyzing hazardous situations.
- Demonstrated understanding of Systems Engineering driven process for achieving ISO 14971 compliance.
- All work shall be performed in accordance with the company’s policies and procedures for design control and risk management.
Job Requirements
Details: Qualifications:
- Master’s in systems engineering
- Formal systems engineering environment
- INCOSE Certified – preferred
- Medical device experience (Quality Management System) – nice to have
- 10 plus years of experience
- Software development is a plus
- Software/Electrical Engineering development is a plus