Systems Engineer-Medical Domain

Orlando, FL, US • Posted 19 days ago • Updated 8 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

  • IT Management
  • Translation
  • Requirements Management
  • Level Design
  • Systems Design
  • NPI
  • Innovation
  • Quality Assurance
  • Design Review
  • Data Management
  • IBM Rational DOORS
  • Research and Development
  • Systems Engineering
  • Mechanical Engineering
  • Firmware
  • Writing
  • Presentations
  • Risk Management
  • ISO 9000
  • EMC
  • Medical Devices
  • Product Development
  • Verification And Validation
  • Testing
  • Electrical Engineering
  • Software Development

Summary

Job Summary:
  • 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.
Responsilities:
  • 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.
Requirements:
  • Understanding of US and international regulatory requirements for medical devices strongly preferred.
  • Experience developing reliability plans.
  • Knowledge of product development processes and best practices.
  • Knowledge of verification and validation testing processes.
  • Electrical or Software development experience is a plus.
  • Master's degree preferred.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 4d9bc26a31d0ec462d5b3c6c3dfe4efe
  • Posted 19 days ago
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