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System Engineer

1 month ago

Winter Park, United States Katalyst HealthCares and Life Sciences Full time
Job Description 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.
  • 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.
  • 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.
Requirements:
  • team of highly skilled engineers that is focused on creating world class health care solutions.
  • Our focus on improving our lives contributes to our amazing work environment and culture.
  • 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.
  • bility 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.