Job Description
A competent electro-mechanical engineer is required to work within the engineering department, delivering projects and technical design support for medical device products. The successful candidate will assist in enhancing current designs and help create sustainable product roadmaps to product end of life.
Main Responsibilities
* Design electrical and mechanical systems.
* Generate and adhere to GMP guidelines.
* Review obsolete component issues and support purchasing in last-time-purchase activities, alternative component sourcing, and implications/implementation planning.
* Familiarity with electronic and electro-mechanical systems design and debug.
* General knowledge of PCs (DOS, Windows, hardware installation).
* Technical competency and analytical skills.
* Computer literacy, particularly in design applications and MS Office.
* Document and execute Process Validations.
* CAPA Management.
Qualifications:
* Hons Degree in Electrical or Mechanical Engineering.
* Experience with electronic and electro-mechanical systems design and debug.
* General knowledge of PCs (DOS, Windows, hardware installation).
* Excellent planning, organisational, interpersonal, and communication skills.
* Proactive, able to work under own initiative or as part of a strong team.
Technical Competencies/Skills:
* Electrical and mechanical design.
* Technical competency and analytical skills.
* At least 3-5 years' experience at an engineering level within a regulated industry, preferably the Medical Device Industry.
* Demonstrable knowledge of ISO 13485 and/or 21CFR820.
* Proficiency in Pro-E, SolidWorks, CAD; computer literacy, particularly in design applications and MS Office (Adobe suite an advantage).
* Document and execute Process Validations.
* CAPA Ownership.
* Accountability and Management.