Software Systems Engineer I focusing on logistics software installation and development, requiring travel and collaboration with international teams for project - related work.
SE
Hybrid System Engineer
Posted last month
About the role
- System Engineer providing technical leadership for new product release and sustaining activity. Collaborating with a team to develop high-quality engineering solutions for medical devices.
Responsibilities
- Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
- Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
- Systems design/architecture and Integration oversight.
- Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions.
- Technical liaison to the program
- Defect/Risk management and Design Reviews
Requirements
- BS degree in engineering
- Experience leading medical, or other regulated industry, product development
- Experience in leading groups to solutions for complex problems
- Experience with deriving and simulating human interactions with devices and device use conditions
- Experience with electronic requirement data management SW – preferably DOORS
- Minimum five years engineering / R&D experience in a rigorous quality-focused environment
- Minimum three years’ experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
- Excellent requirements and specification writing skills
- Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
- Ability to build and maintain effective cross-functional and cross-organizational relationships
- Excellent oral, written and presentation skills
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard
- In depth knowledge in developing and testing products to IEC62336 EMC standard
Job title
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