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Biocompatibility Engineer

Focus Resourcing
Job LocationCaerphilly
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

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
  • Keep GOP and associated templates updates
Skills
  • Bachelors 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 properties of devices and materials.
    • Ability to work with a Team in accordance with company objectives.
    • Ability to define problems, collect and analyse data, establish facts, and draw valid conclusions.
    • Ability to verbally communicate ideas and issues effectively to other team members and management.
    • Actively network with the internal and external scientific, technical, and regulatory community to maintain state of the art knowledge.
    • Partner with Quality to support the development, maintenance and adherence to quality systems and continuous process improvement.
    • Partner with product development and regulatory functions to ensure new and sustaining products meet all necessary requirements.
Benefitso 38.5 hours per week (Mon-Thurs 8.30am-5.00pm, Fri 8.30am-3.30pm)o 4 days per month WFHo 25 days holiday (plus bank holidays)o Pension - salary sacrifice (3% ER / 5% EE)o Annual company performance bonuso Annual pay reviewo Benefits - Health cash plan, income protection, life assurance (2 x salary), holiday trading, monthly benefit fund to use or put in pension potRequired skills
  • 1respiratory

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