Bio-Medical Design Engineer
IT – Designer
Pretoria/Centurion – Gauteng
ENVIRONMENT:
Our client is a top player in South Africa’s wound care scene, known for their fantastic service and support. They’re on the hunt for a Bio-Medical Design Engineer to join their team! Your job will be to develop cost-effective, regulation-approved medical devices and coordinate their production. You’ll need a B.Eng. degree and at least a year of post-grad experience.
DUTIES:
- Management of a cleanroom medical device production line and staff.
- Design and development of medical devices.
- Obtaining regulatory approvals for strategic products.
- Maintenance of the documentation including Design Dossier, Instrument Design Dossier, Risk Management File and Design History File (DHF) dossiers.
- Maintain Quality Documentation (such as design process, verification, validation).
- Managing the design transfer process with other departments, from design release to implementation.
Other responsibilities:
- Design Review meetings.
- Perform physical testing of products in laboratory.
- Ensure QC parameters are strictly adhered to.
- Improvement of existing processes and procedures.
- Source and liaise with suppliers or sub-contractors for various product requirements.
- Design transfer .
- Creating and maintaining Design and Development Plans.
REQUIREMENTS:
Required minimum education: B.Eng.
Required minimum competencies: 1 year post graduate experience
Required minimum experience:
- Strong technical and theoretical capability.
- Understanding of manufacturing processes.
- Project Management proficient.
ATTRIBUTES:
- Excellent communication skills
- Goal driven
- Organised