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

System Engineer

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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