Job Description
A competent electro-mechanical engineer to work within the engineering department, to deliver projects and technical design support for medical device products. To assist in enhancing current designs and help create sustainable product road maps to product end of life. To create, update and re-issue associated documentation through the company change process. To work on new design concepts and projects identified as to be transferred to the current manufacturing location and provide technical expertise during the project release phases. To provide a high-level knowledge transfer to help engineering team provide diagnostic, test, debug and support to the manufacturing area.
Key Responsibilities
1. Electrical / mechanical design.
2. Generation and adherence to GMP
3. To review obsolete component issues and support purchasing in the 'last-time-purchase' activities, alternative component sourcing and implications/implementation planning.
4. Familiar with electronic and electro-mechanical systems design and debug.
5. A general knowledge of PCs (DOS, Windows, hardware installation).
6. Technical competency and analytical skills
7. Computer literacy, in particular design applications and MS Office.
8. Document and execute Process Validations
9. CAPA Management
Qualification:
10. Hons Degree Electrical / Mechanical Engineering
11. Experienced with electronic and electro-mechanical systems design and debug.
12. A general knowledge of PCs (DOS, Windows, hardware installation)
13. Excellent planning, organisational, interpersonal and communication skills
14. Proactive, with the ability to work under own initiative/strong team player
Technical Competencies/skills:
15. Electrical / mechanical design.
16. Technical competency and analytical skills.
17. At least 3-5 years' experience at engineering level within a regulated industry, preferably the Medical Device Industry
18. Demonstrable knowledge of ISO 13485 and/or 21CFR820
19. Pro-E, Solid-works, CAD; Computer literacy, in particular design applications and MS Office (Adobe suite an advantage)
20. Document and execute Process Validations
21. CAPA Ownership
22. Accountability & Management