Senior R&D Electronics Engineer


Our client a high potential medical device start up currently seeking a Senior Electronics Engineer to join their team. Reporting to the Electronics Engineering Director the Senior Electronics Engineer will provide technical leadership across all stages of development of electronic systems for medical devices, including design, testing, manufacturing, documentation, etc.


Role/Responsibilities:

• Development of Electronics systems for medical devices, including:
  • Architecture definition
  • Requirements specification
  • Prototype design
  • Risk assessment, DFMEA
  • Manufacturing specification
  • Schematics and Bill of Materials creation
  • PCB design
  • EMC testing and troubleshooting.
  • Interaction with and/or management of external contractors / suppliers
  • Support preparation of compliance package for product certification, including:
    • IEC 60601-1 and IEC 60601-1-11 (Basic Safety and Essential Performance)
    • IEC 60601-1-2 (Electromagnetic compatibility)
    • Support product verification activities, including:
      • Creation of verification plan, verification protocols and test method
      • Coordinate test execution (both internally and with external test houses)
      • Creation of verification reports
      • Support preparation of budget for development activities.
• Project-manage development items to ensure that all commitments are achieved within aggressive timelines while meeting agreed budget.
• Ensure full compliance with all Quality, Regulatory, Health and Safety procedures.
• Support design transfer to manufacturing.
• Provide effective internal and external communications and reporting.
• Train, develop and lead R&D engineers and other technical staff. Assign tasks and provide support and assistance to the development team
• Engage with the QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives

• Minimum Bachelor’s Degree in Electronics/Electrical Engineering
• 5+ years previous experience, preferable in a Medical Devices environment with knowledge of medical device product development, certification and manufacturing processes
• Knowledge of RF and radio and associated standards and certification processes is desirable
• Highly competent in design of Analog and Digital Electronics
• Highly experience in use of tools for Electronics Design (schematics capture, PCB design, etc) – OrCAD platform preferred.
• Highly experience in electronics testing / troubleshooting
• Experience with Electronics manufacturing
• Competent with RF technologies
• Knowledge of IEC 60601-1 standard series (including IEC 60601-1-2 (EMC) and IEC 60601-1-11 (Home use devices))
• Working knowledge of IEC 62304 desirable
• Experience in EMC testing
• Experience with firmware (C/C++ coding) desirable
• High level computer skills including Microsoft Excel, PowerPoint and Word and MS Project
• Experience working in Agile manner with Jira, Confluence or similar desirable