Electronics and embedded software engineer medical devices
Electronics and Embedded Software 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;
- Adhere to the Company’s Design Control and Change Control procedures;
- Contribute to the improvement of the Company’s processes for Design Controls and Change Control;
- Adhere to the Company’s Quality policy and objectives, and the requirements of the Company’s Business Management System through Q-Pulse;
- Maintain up-to-date knowledge of and ensure compliance with Standard Operating Procedures relevant to role.
Experience and Qualifications Required
- Postgraduate 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
- Knowledge of EN 62304 (Software development life cycle);
- Knowledge of ISO 13485 and 21CFR part 820 QMS standards;
- Knowledge of product risk management process particularly ISO 14791;
- Knowledge of EN 60601-1: 3rd Edition (general electrical safety) and EN 62366 (usability);
- Knowledge of ISO 10993-1 Biocompatibility;
- Knowledge of Design for Manufacture and Service best practice;
- Knowledge of FMEAs.
Key Skills and Competencies
- 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;
- The ability to learn quickly and establish a high degree of knowledge and expertise in own field;
- The ability to deliver to tight deadlines, work well under pressure to a high standard of accuracy, and in an organised, intelligent, structured and methodical way;
- Strong prioritisation, time management and collaborative relationship skills, with the ability to adapt easily to changing priorities;
- Positive minded, solution-oriented and the ability to strive for success regardless of difficulties encountered;
- Excellent interpersonal, communication, presentation and technical report writing skills;
- Confident and assertive personality, an open and approachable manner, strong analytical skills, and be highly driven, self-motivated and a strong team player;
- Convey the Company in the most professional manner and to support fully at all times the Company’s desire to be the best;
- Experience of working in a small to medium sized company;
- IT literate, with proficiency in MS Office, SharePoint and ERP software.