Mechanical Engineer

Our Client is looking for a competent Electro-Mechanical Engineer to work within the engineering department, to deliver projects and technical design support for medical device products.

Assist in enhancing current designs and help create sustainable product road maps to product end of life.

Create, update and re-issue associated documentation through the company change process. 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. Provide a high-level knowledge transfer to help engineering team provide diagnostic, test, debug and support to the manufacturing area.

Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

* Electrical / mechanical design.
* Generation and adherence to GMP
* To review obsolete component issues and support purchasing in the 'last-time-purchase' activities, alternative component sourcing and implications/implementation planning.
* Familiar with electronic and electro-mechanical systems design and debug.
* A general knowledge of PCs (DOS, Windows, hardware installation).
* Technical competency and analytical skills
* Computer literacy, in particular design applications and MS Office.
* Document and execute Process Validations
* CAPA Management

Qualifications:
* The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* Hons Degree Electrical / Mechanical Engineering.

Experience:
* Experienced with electronic and electro-mechanical systems design and debug.
* A general knowledge of PCs (DOS, Windows, hardware installation)

Technical Skills:
* Electrical / mechanical design.
* Technical competency and analytical skills.
* At least 3-5 years' experience at engineering level within a regulated industry, preferably the Medical Device Industry
* Demonstrable knowledge of ISO 13485 and/or 21CFR820
* Pro-E, Solid-works, CAD; Computer literacy, in particular design applications and MS Office (Adobe suite an advantage)
* Document and execute Process Validations
* CAPA Ownership
* Accountability & Management