Job Description
A skilled electro-mechanical engineer is required to work within the engineering department, delivering projects and technical design support for medical device products. The role involves assisting in enhancing current designs and creating sustainable product roadmaps to ensure successful product lifecycles.
Key Responsibilities:
* Develop electrical and mechanical designs.
* Ensure compliance with GMP regulations.
* Review and address obsolete component issues, supporting purchasing activities and implementing alternative sourcing solutions.
* Familiarize yourself with electronic and electro-mechanical systems design and debugging.
* Hold a general knowledge of PCs (DOS, Windows, hardware installation).
* Demonstrate technical competency and analytical skills.
* Show proficiency in computer literacy, particularly in design applications and MS Office.
* Execute process validations and CAPA management.
Qualifications:
* Hons Degree in Electrical or Mechanical Engineering.
* Experience in electronic and electro-mechanical systems design and debugging.
* General knowledge of PCs (DOS, Windows, hardware installation).
* Excellent planning, organizational, interpersonal, and communication skills.
* Ability to work proactively and as part of a strong team.
Technical Competencies/Skills:
* Electrical and mechanical design expertise.
* Strong 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, Solid-works, CAD, and Computer Literacy.
* Document and execute Process Validations.
* CAPA Ownership and Accountability.