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 surgery.
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
- 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
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.