Biocompatibility & Toxicology Senior Scientist

DEKA Research & Development has an immediate opening for a Biocompatibility & Toxicology Senior Scientist to join our team focused on medical device and combination product development.

The individual in this role will work directly with Research & Development, Regulatory & Clinical Affairs and Quality Engineering to formulate and execute biocompatibility and toxicological evaluation strategies that support development objectives and world-wide regulatory approvals.  How you will make a difference as a Biocompatibility & Toxicology Senior Scientist :

• Work in close association with customers and development teams to define and execute biocompatibility / toxicology evaluations, including establishing requirements for biological safety of medical devices and combination products Lead the preparation and conduct of biocompatibility / toxicology test programs Lead interactions with external consultants and contract laboratories including in-person meetings, teleconferences, and other communications as needed to support program objectives Develop and deploy mechanisms to continually maintain state of the art knowledge and understanding related to biocompatibility and toxicological safety of medical devices, including relevant standards and test methods.  Insure processes and procedures maximize resource efficiency and minimize time to market Insure the organization stays up to date on global regulatory changes to medical device biocompatibility standards and requirements through monitoring regulatory authority and industry resources Coach and mentor internal and external partners on effective strategies and tactics Interface with customers on biocompatibility and toxicology issues Skills you will need to be successful : MS in a technically related field (toxicology, materials science, chemical engineering, biomedical engineering or related).

Minimum of 7 years direct work experience in a medical device and / or combination product development role with demonstrated success in planning and conducting biocompatibility and toxicological evaluations Expertise in U.S. and international medical device biocompatibility requirements including ISO 10993 standards, Good Laboratory Practices, and guidance from regulatory authorities Demonstrated practical knowledge of the laboratory methods and analytical techniques associated with medical device and / or combination product biocompatibility and chemical characterization evaluations Demonstrated ability to establish consensus and work collaboratively across functions and development teams Excellent written and verbal communication skills including the ability to effectively communicate at all levels of the organization and with external partners About DEKA :