**What you will do:**

+ Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests. And support product transfers to other plants/facilities.
+ Partners with cross-functional project team members to define evaluation / verification strategies of medical devices and review, evaluate, interpret, and apply internal and external guidance documents as they relate to biocompatibility.
+ Identify and analyze materials, design, and process challenges to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.
+ Responsible for identifying critical process factors and their effects on biological safety.
+ Develop technically sound test campaigns (i.e. biocompatibility and chemical testing)., protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team, test laboratories, and suppliers; develop an...