Technical Assistant - Medical Devices - Bio-compatibility

Location Leeds
Discipline: Medical Device
Job type: Permanent
Salary: ££30000 - £40000 per annum + Excellent Benefits
Contact name: Ben George

Contact email: admin@superadmin.sciencesr
Job ref: BBBH3260_1640268274
Published: about 1 month ago
Startdate: ASAP

Role: Technical Assistant - Biocompatibility / Medical Devices Product Safety

Location: Leeds

Salary: Highly Competitive

Our client is looking for a new addiction to their New Product Development Team. You will have experience within Medical Devices and Bio-Compatibility. This is an excellent opportunity to join a family run growing business within West Yorkshire. You will also have a background within NPD and Medical Device Product Safety.

Role:

  • Preparing biocompatibility plans and reports for new and existing products to ensure compliance with ISO 10993 and changing regulatory requirements
  • Following a risk-based approach, determine the testing required and liaise with the relevant test houses to ensure this is carried out accurately and in a timely manner.
  • Support the R&D Department during the design and development of a product by providing technical guidance on biocompatibility requirements.
  • Assessing the impact of changes to existing products and processes on the biological safety of a device.
  • Additional duties may include carrying out shelf-life studies, including packaging and product stability.
  • Updating PFMEA files.

Person:

  • A good understanding of biocompatibility issues
  • A skilled technical writer.
  • Previous experience in medical device product safety.
  • Degree within Biology / Microbiology / Chemistry