Electronics Technical Lead Engineer - Medical Devices
£Neg + benefits
West Sussex / Surrey
Our clients designs and manufactures an innovative range of medical devices products. Due to exciting expansion plans for their product range they have an immediate requirement for an experienced medical devices Electronics and Embedded Software Development Engineer to deliver technical expertise to their new product development projects.
Main Duties and Responsibilities
- Technical Lead role in product development projects;
- Extensive involvement in idea development, requirement capture, product design, verification and validation activities;
- Generate and approve technical documentation in accordance with the Company’s standard operating procedures and international standards;
- Manage and communicate efficiently with external design resources when required;
- Passionate about developing medical devices from early ideas or concepts to final products;
- Hands-on self-starter with excellent attention to detail;
- Proactive approach to problem solving with experience in FMEA and/or FTA techniques;
Experience and Qualifications Required
- Degree in technical / engineering disciplines;
- 5 years’ experience in embedded software design (preferably C based languages)
- 5 years’ experience in electronic (digital and analogue) design
- Project management skills
- Experience of complete project lifecycle from concept to production
- Able to lead risk analysis activities
- Working experience in mechanical, electronics or embedded SW development for medical devices.
- Driving licence is essential.
- IOS and Android app development
- Working knowledge of Altium / ARM processors, and microchip processors
- Working knowledge of SolidWorks Mechanical or PCB CAD
- EN 62304 (Software development life cycle); ISO 13485 and 21CFR part 820 QMS standards; product risk management ISO 14791; EN 60601-1: 3rd Edition (general electrical safety) and EN 62366 (usability); ISO 10993-1 Biocompatibility; Design for Manufacture and Service best practice; FMEAs.
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