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 Bachelors/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
• Youre 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 andglobal 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)