Sr. Biocompatibility Scientist

Job Description Summary  

We are seeking an experienced, high caliber Scientist II who will make an important contribution to patient safety by supporting projects and programs related to the biocompatibility of medical devices, materials, and processes. This role will be responsible for submitting test devices to laboratories, managing test progress, and serving as the primary contact for the labs. The Scientist II will work closely with cross-functional teams to provide biocompatibility deliverables (biocompatibility plans/reports/justifications) in compliance with global regulatory requirements such as ISO 10993. The role requires comprehensive knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance affecting assigned devices (Class I to Class III). The candidate must be able to support the biocompatibility team in correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices. The candidate must have strong ability to interpret biological test results and detailed scientific information. 

Essential Responsibilities: 

• Develop technically sound protocols, reports, and regulatory summaries in collaboration with