PURPOSE OF THE POSITION
The engineer will primarily be involved in existing and new product research design and development and associated projects in the medical device industry including interventional cardiology otolaryngology and many other medical devices.
KEY ROLES AND RESPONSIBILITIES:
- Product design and development including prototyping.
- Development of manufacturing techniques and optimization of production processes.
- Test method development and coordinating of product testing.
- Compilation of reports for regulatory submissions.
- Process validation
- Software validation
- Interface with production and other departments including training and providing technical support.
- Work within the quality management system of the company and assist in complying with ISO 13485.
Requirements
KNOWLEDGE SKILLS AND EXPERIENCE REQUIRED:
- Strong engineering knowledge and skills
- Highly analytical with exceptional attention to detail and good organizational skills
- Good experience with a computer aided design package (preferably SolidWorks)
- Goalfocused with a track record of "getting things done"
- Problemsolving ability
- Ability to work well in a team and efficiently within a highly regulated environment
- Excellent reportwriting and communication skills
- Creative
QUALIFICATIONS REQUIRED:
- BSc (Eng.) or BEng in mechanical or mechatronic engineering as a minimum. MSc in Engineering or MEng (especially Biomedical Engineering) is preferred
RECOMMENDED ADDITIONAL QUALIFICATIONS AND EXPERIENCE:
- Experience with Solidworks is preferred
- Experience working within an ISO 13485 environment will be advantageous
Benefits
- Medical Aid Contribution
- Provident Fund Contribution
KNOWLEDGE, SKILLS, AND EXPERIENCE REQUIRED: Strong engineering knowledge and skills Highly analytical with exceptional attention to detail and good organizational skills Good experience with a computer aided design package (preferably SolidWorks) Goal-focused, with a track record of "getting things done" Problem-solving ability Ability to work well in a team and efficiently within a highly regulated environment Excellent report-writing and communication skills Creative QUALIFICATIONS REQUIRED: BSc (Eng.) or BEng in mechanical or mechatronic engineering, as a minimum. MSc in Engineering or MEng (especially Biomedical Engineering) is preferred RECOMMENDED ADDITIONAL QUALIFICATIONS AND EXPERIENCE: Experience with Solidworks is preferred Experience working within an ISO 13485 environment will be advantageous