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Job Description
Senior R&D Electronics Engineer
Our client, a high potential medical device startup, is 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, and documentation.
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 and IEC Basic Safety and Essential Performance)
- IEC Electromagnetic compatibility)
- Support product verification activities, including:
- Creation of verification plan, verification protocols, and test methods
- Coordinate test execution (both internally and with external test houses)
- Creation of verification reports
- Support preparation of budget for development activities
- Projectmanage 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 and support the achievement of the business quality objectives.
Skills/Experience:
- Minimum Bachelor's Degree in Electronics/Electrical Engineering
- 5+ years previous experience, preferably 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 the design of Analog and Digital Electronics
- Highly experienced in the use of tools for Electronics Design (schematics capture, PCB design, etc.) – OrCAD platform preferred
- Highly experienced in electronics testing/troubleshooting
- Experience with Electronics manufacturing
- Competent with RF technologies
- Knowledge of IEC standard series (including IEC EMC) and IEC 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, Word, and MS Project
- Experience working in an Agile manner with Jira, Confluence, or similar desirable
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