Sr Bio/ Toxicologist

This position has the responsibility and authority to coordinate studies providing documented scientific support, and direction for biological evaluation of medical devices and materials. This position will establish and maintain a biological evaluation program that integrates risk management. This position provides technical guidance to engineers and/or project management during the design process to ensure material selection and device configurations that are biologically safe for use. This position will improve the biological evaluation process using databases, information systems, and training programs.

Responsibilities may include the following and other duties may be assigned.

• Provides biological safety assessment to achieve ISO 10993 compliance and to support product development activities.
• Provides guidance in the development of product and selection of materials to ensure that released designs meet biological safety requirements.  The Senior Toxicologist is responsible for the timely completion of technical deliverables.
• Prepares documentation of biological assessment efforts using sound scientific principles.  Coordinates biological testing activities by partnering with MDT Physiological Research Laboratories, NAmSA, WuXi AppTec, Toxicon, or other approved laboratory as appropriate. Provides primary interface with MDT Physiological Research Laboratories for MDT XMD.
• Establishes and integrates risk management process as part of the biological evaluation program in a manner that complies with ISO 10993.
• Assesses the biological safety impact from manufacturing and supplier changes on patient-contacting devices.
• Consults on the biological safety impact from device field issues
• Develops or identifies resources and provides training to aid product development activities with biological evaluation process. (Web-based biomaterials support, biomaterials testing databases).
• Mentors engineers
• All activities must be performed in compliance with the Quality System
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement:  Less than 10%

Responsibilities may include the following and other duties may be assigned.

• Responsible for biological safety assessment in compliance with ISO 10993, FDA, and other geographical requirements for medical devices.
• Provides guidance in the development of products and selection of materials to ensure that released products meet biological safety requirements.
• Uses applicable standards, written procedures, statistical processes, and academic understanding of toxicology and biocompatibility principles to accomplish tasks.
• Authors biocompatibility evaluations and/or toxicological risk assessments for regulatory submissions and compliance by analyzing, interpreting, and drawing conclusions from biocompatibility testing, extractable and leachable chemical characterization, and biological evaluations.
• Leads team in product failure investigations, interacting across functions and management levels.
• Engages in continuous improvement activities aimed at increasing efficiency and productivity, contributing to the overall operations and to the achievement of organizational goals.
• Maintains substantial knowledge of state-of-the-art principles and theories and may contribute to scientific literature and conferences.

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

• Master of Science or PhD in toxicology, physiology, or related discipline preferred.
• Strong problem solving and analytical skills.
• Able to apply advanced scientific principles.
• Good oral and written communication skills.
• Excellent presentation skills.
• Able to handle multiple tasks/projects and manage priorities accordingly.
• Able to work in a team environment, including cross-functional teams, and exert influence without alienating others.
• Knowledge of biological impact of foreign materials in the human body.
• Knowledge of applicable ASTM, ISO, FDA, and EN standards.
• Understanding of ISO 10993 - Biocompatibility standards.
• Computer proficiency using word processors, spreadsheet, project management, and statistical software programs.