Senior R&D Electronics Engineer
Our high potential medical device startup seeks a Senior Electronics Engineer to provide technical leadership in the development of electronic systems for medical devices.
Reporting to the Electronics Engineering Director, the successful candidate will be responsible for:
- Developing electronics systems for medical devices, including architecture definition, requirements specification, prototype design, and risk assessment
- Creating manufacturing specifications, schematics, and Bills of Materials
- Designing and testing Printed Circuit Boards (PCBs) to ensure electromagnetic compatibility (EMC)
- Interacting with and/or managing external contractors and suppliers
- Supporting the preparation of compliance packages for product certification, including IEC 60601-1 and IEC 60601-1-11
- Coordinating test execution and creating verification reports
- Managing development budgets and timelines while ensuring compliance with quality, regulatory, health, and safety procedures
- Supporting design transfer to manufacturing and providing effective internal and external communications
- Training, developing, and leading R&D engineers and other technical staff
- Engaging with the Quality Management System (QMS) to ensure delivery of the overall quality strategy
The ideal candidate will have:
- A minimum Bachelor's Degree in Electronics/Electrical Engineering
- 5+ years of experience in a Medical Devices environment, with knowledge of medical device product development, certification, and manufacturing processes
- Knowledge of RF and radio standards and certification processes
- Highly competent in the design of Analog and Digital Electronics
- Experience with electronics testing, troubleshooting, and manufacturing
- Knowledge of IEC 60601-1 standard series, including IEC 60601-1-2 and IEC 60601-1-11
- Working knowledge of IEC 62304 and experience with firmware (C/C++ coding)
- High-level computer skills, including Microsoft Excel, Power Point, Word, and MS Project
- Experience working in an Agile manner with Jira, Confluence, or similar