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Job Description
Senior R&D Electronics Engineer sought for medical device startup to lead development of electronic systems for medical devices.
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.
Key Responsibilities:
- Develop electronics systems for medical devices, including architecture definition, requirements specification, prototype design, risk assessment, and manufacturing specification
- Create schematics and Bill of Materials, and design PCBs
- Conduct EMC testing and troubleshooting, and interact with external contractors/suppliers
- Support preparation of compliance package for product certification, including IEC 60601-1 and IEC 60601-1-11
- Coordinate test execution and creation of verification reports
- Project-manage development items to ensure timely and budgeted delivery
- Ensure full compliance with Quality, Regulatory, Health and Safety procedures
- Support design transfer to manufacturing and provide effective internal and external communications and reporting
- Train, develop, and lead R&D engineers and other technical staff
Requirements:
- Minimum Bachelor's Degree in Electronics/Electrical Engineering
- 5+ years previous experience in 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.)
- Experience with Electronics manufacturing and 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 and firmware (C/C++ coding) desirable
- High level computer skills including Microsoft Excel, Power Point, Word, and MS Project
- Experience working in an Agile manner with Jira, Confluence, or similar desirable