Experienced Medical Device Engineer with a demonstrated history of working within the medical device industry. Skilled in new product introductions, Sterilisation Validations (ETO & Gamma irradiation), Risk Management, Biocompatibility testing, EU MDD/MDR(New) and FDA requirements. Strong Engineering professional with a Post Graduate Degree in Biomedical Science. 

Title: Design Quality Engineer 

Availability: 1st April 

Location: South Wales. Hybrid / Remote preferred 

Hourly rate: Approx £85 p/h depending on travel requirements 

Services:
• Experience of GMP.
• Experience of risk analysis in accordance with ISO 14971.
• Experience of ISO 13485
• Experience of FDA – 21 CFR 820.
• Experience of Auditing.
• Experience of validations (Process, Sterilisation, Design).
• Experience of new product introductions, design changes and regulatory device classification (EU and FDA)
• Human Factors Engineering experience as per IEC 62366-1
• ISO 10993 Biocompatibility experience