Bio-Medical Design Engineer

• 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.

• 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.

• Strong technical and theoretical capability.
• Understanding of manufacturing processes.
• Project Management proficient.

• Excellent communication skills
• Goal driven 
• Organised 

While we would really like to respond to every application, should you not be contacted for this position within 10 working days please consider your application unsuccessful.