Materials Scientist

Key Areas of Responsibility:

• Collaborate with Biocompatibility Engineers and Toxicologists to drive the biological evaluation strategy of S&RC medical devices by contributing to the development of the Biological Evaluation Plans, Biological Evaluation Reports, Toxicological Risk Assessments, and analytical chemistry data analysis to demonstrate biological safety
• Perform material assessments and testing needed to identify hazards and assess biocompatibility for new product development and product design changes, including material matrix development and management
• Support project teams in achieving state-of-the-art compliance with global biocompatibility standards and guidelines
• Develop and review of biocompatibility and materials-based product requirements with development teams to ensure that they are complete and testable
• Support the risk management process where it relates to material and biocompatibility risks, ensuring that risks are appropriately managed by providing input to senior team members
• Develop materials test plans and test protocols to be executed to effectively and efficiently achieve project goals
• Report on test results, drawing scientifically correct conclusions to assist in project decision making and verification of material/product safety
• Participate in Formal Technical Reviews with cross functional group to plan and execute testing strategies
• Communicate and coordinate testing with internal and external test labs
• Execute test procedures both personally and using test technicians to support product development, verification, and validation activities
• Execute long-term accelerated aging studies, including impact of shelf life, useful life, cleaning and disinfection agents, and other use case inputs, to assess product material stability
• Investigate material failures and coordinate corrective actions with project teams
• Analyze and interpret data generated through material test procedures using all tools and software available with accuracy and correctness display data in an easy to interpret manner
• Participate in the scouting of new materials, manufacturing processes, finishing technologies, and reprocessing methods which make new designs and functions in Philips S&RC products possible and safe
• Contribute to long term competence development in materials science at S&RC by participating in discussions and providing input to identify needs and gaps focus on personal technical development
• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms)
• Work cross-functionally and collaborate with R&D, quality, regulatory, CROs, competent authorities, internal/external scientists and other stakeholders

Job Knowledge, Skills & Experience:

• You have a minimum of a Bachelor's/MS Degree in Chemistry, Materials Science, Materials Engineering, Chemical Engineering, Bioengineering or similar disciplines
• You have a minimum of 1 year of experience as a materials scientist or equivalent, with a focus on product or process development and materials testing and characterization
• You have some experience analyzing chemical and physical properties of materials to draw scientifically accurate conclusions
• You have experience using material characterization and analytical chemistry testing instrumentation in a lab environment
• You're able to collaborate with other disciplines, internal and external partners, and contract research organizations
• You work well in a cross-functional team and can also work on projects independently
• You have proven experience in research and development of medical devices (strongly preferred)
• You understand and have experience with ISO 10993 standards for materials analysis and risk assessments, with knowledge of FDA, EU MDR and global medical device regulations, requirements, and standards (strongly preferred)
• You have strong root cause analysis experience and the ability to perform failure mode investigations to support CAPA process (preferred)