Senior Biocompatibility Specialist in Deeside

About Convatec: Pioneering trusted medical solutions to improve the lives we touch. Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring.

Position Overview: As part of Convatec’s Applied Research organization within the Biomedical Sciences team, the Senior Biocompatibility Specialist is responsible for execution of biocompatibility projects requiring deep expertise in biocompatibility for New Product Development (NPD), Life Cycle Management (LCM) and Research projects. From a technical standpoint, the Senior Biocompatibility Specialist will apply subject matter expertise in biocompatibility to design and perform the technical approach to biological evaluations for products, analyze data, reflect on results, report out on data to project teams and complete biological evaluation documentation in line with ISO 10993 series of standards and the quality system.

Key Responsibilities:

• Deliver biological evaluations of new and existing devices in close and effective collaboration with the relevant project teams.
• Evaluate projects and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.
• Leverage internal capabilities to support biocompatibility projects.
• De-risk new medical devices and research projects early in the development process in order to deliver feedback and data that support device development.
• Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.
• Understand biocompatibility strategies that are formed in consideration of product and process changes, gaps in materials, design and process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.
• Make positive contributions to recommend approaches to, and support updating/ developing procedures for internal and external guidance documents as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA).
• Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable, chemical characterization and biological evaluations.
• Write, edit, and/or approve technical documentation.
• Communicate effectively to expert and non-expert audiences with regular project updates in meetings as well as in the form of presentations and reports.
• Effectively collaborate with project management, R&D, Regulatory, manufacturing, process engineering Global Laboratory Services etc. teams, ensuring teams are aligned on key goals, deliverables, resource needs, timelines etc.
• Promote teamwork within and across departments, sharing experiences and best practices.

Skills & Experience:

• +5 years related to biocompatibility evaluations and/or toxicological risk assessments of medical devices.
• Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
• Capable of developing and driving a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
• Ability to demonstrate a high level of creativity and independence in areas of assigned responsibility and has good command of the relevant scientific and technical literature.
• Demonstrates excellent analytical and problem-solving skills and ability to interpret data from a variety of sources.
• Excellent verbal/written communication skills and the ability to work well in cross functional teams.
• Ability to collaborate effectively to troubleshoot issues, identify solutions and optimise strategies for implementation.
• Demonstrate ability to time manage multiple projects effectively and efficiently and adapt to changing priorities as required.
• Very strong communication and project management skills with multiple teams from different disciplines.

Qualifications/Education:

• BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology.
• Advanced degree (MS or PhD) in these fields preferred.

Travel Requirements: Up to 20% travel domestically and overseas including overnight travel as appropriate.

Working Conditions: Hybrid working once Convatec moves to Manchester site in 2027 with expectation of around 1 day a week in the office with flexibility according to business needs.