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Biocompatibility Engineer

Posted 20 days ago

  • Caerphilly, Gwent
  • Any
  • External
  • Expires In 2 months
We are looking to recruit for a Bio-compatibility Engineer, you will be a part of the R&D team that is responsible for implementing technical strategies, evaluating and developing products, and providing a superior level of technical support.
Duties:
The main responsibilities involve the biological safety risk assessment, by chemical analysis and characterisation, of medical devices in development.
You develop protocols, reports, and regulatory summaries in collaboration with cross-functional teams, laboratories and suppliers.
Management of external test laboratories and ensure compliance with global regulatory requirements and standards related to biological safety.
You are also entrusted with defining testing strategies for materials, design and process that satisfy cost and technical requirements as well as analysing bio-compatibility testing (
Review and approves external chemical analysis reports
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Skills
Bachelor's degree or higher in Biochemistry, Chemistry, Chemical Engineering, (Bio)Medical Engineering or Physics.
In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.
In-depth knowledge of medical device regulations and standards
Knowledge of analyticaly/physical/organic chemistry and ability to translate this knowledge into a consistent work programme to analyse the proper...
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