SKILLS

• Organic Chemistry or General Chemistry
• Understanding of principles, and techniques of toxicology and biocompatibility 3-5 years of experience in medical device industry or biocompatibility research organization working on biocompatibility of medical device
• Deep working knowledge of ISO 10993 standards for biocompatibility Ability to coordinate work through outside service laboratories (e.g. extractables/leachables testing and non-clinical safety studies)
• Experience with sample preparation/extraction/ separation techniques for material analyses
• Experience in polymers, analytical chemistry Experience in instrumentation analysis - e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
• Experience interpreting laboratory data and working with mathematical concepts relevant to chemical or biological testing
• Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
• Experience working in Design Control environment; Auditing Skills, Knowledge of quality systems and regulatory submissions
• Strong oral and written communication skills
• Ability to multitask and track multiple projects at various stages
• Attention to detail
• Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges.
• Strong computer and general software skills

EDUCATION

• Bachelors Degree in Biological Sciences or Toxicology or Chemistry with courses in Life Sciences