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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
- 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 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.
Benefits
o 38.5 hours per week (Mon-Thurs 8.30am-5.00pm, Fri 8.30am-3.30pm)
o 4 days per month WFH
o 25 days holiday (plus bank holidays)
o Pension - salary sacrifice (3% ER / 5% EE)
o Annual company performance bonus
o Annual pay review
o Benefits - Health cash plan, income protection, life assurance (2 x salary), holiday trading, monthly benefit fund to use or put in pension pot
