Biocompatibility Engineer

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 analytical/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

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