Description
Systems Engineer- Global Industry StandardsA well recognize global medical device company is looking for an experienced system engineer to join a growing team and bring project engineering leadership and regulated industry global standards experience. This position is a high priority as it is very visibile in the group and will work cross-functionally with global offices.
POSITION DESCRIPTION:
- Own the identification and management of Global Industry Standards
- Own the Requirements Analysis activities associated with deriving System & Product Requirements from Global Industry Standards
- Co-Own with Project Systems Engineer the interpretation and derivation of System/Product Requirements from Global Industry Standards
- Ensure the appropriate compliance evidence is defined, gathered, and properly traced
- Support the business as a Global Industry Standards Subject Matter Expert
- Own the assessment of how Medical Device Industry Standards can be used to show compliance to Regulations/Directives/Laws in the applicable global geographies
- Create and Manage Verification Plan for Standards Compliance Testing.
- Coordinate with Internal and External Test organizations for the effective and efficient execution of verification activities
- Support development projects with Global Industry Standards Engineering Subject Matter Expertise
BASIC QUALIFICATIONS:
- 10+ years of experience with Bachelors Degree; or
- 5+ years of experience with Masters Degree
- 10 years in medical device product development, or other highly regulated environment.
- 5 years of experience dealing with Medical Device and RF Standards - assessment, implementation, and compliance evidence
- 5 years of Systems Engineering experience
- Supply Chain Management requirements flow experience
- Able to help form and work in a team environment