Electromechanical Research / Design Engineer - Medical Devices
To £42.5k + benefits
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 Research and Development Engineer passionate about developing medical devices from early ideas or concepts to final products to work within the R&D team delivering technical expertise to 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;
- Contribute to the improvement of the Company’s processes for Design Controls and Change Control;
- Work to the Company’s Business Management System through Q-Pulse and Design Control and Change Control procedures;
Qualifications and Knowledge
- Degree in technical / engineering discipline
- ISO 13485 and 21CFR part 820 QMS standards;
- Product risk management process particularly ISO 14791;
- EN 60601-1: 3rd Edition (general electrical safety) and EN 62366 (usability);
- Mechanical, electronics or embedded SW development for medical devices.
- Driving licence is essential.
- ISO 10993-1 Biocompatibility;
- EN 62304 (Software development life cycle);
- Design for Manufacture and Service best practice;
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;
- Experience of working in a small to medium sized company;
- IT literate, with proficiency in MS Office, SharePoint and ERP software.