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1. Knowledge of ISO 10993 standards
2. Background in Toxicology/Biology
3. Excellent written and oral presentation skills
TOXICOLOGIST POSITION DESCRIPTION:
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.
TOXICOLOGIST POSITION RESPONSIBILITIES:
• 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 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, Toxikon, 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%.
• Possible option to relocate to Goleta, CA after 12 months.
• Bachelor of Science degree required.
YEARS OF EXPERIENCE
• 3+ years of experience preferred in the medical device or pharmaceutical industry performing or overseeing biological safety assessments, related risk assessments, and or equivalent experience.
SPECIALIZED KNOWLEDGE REQUIRED
• In-depth knowledge of biological impact of foreign materials in the human body.
• Knowledge of applicable ASTM, ISO, FDA and EN standards. An in-depth understanding of ISO 10993 – Biocompatibility standard.
• Computer proficiency using word processors, spreadsheet, project management, and statistical software programs is required.
• Master of Science minimum, PhD preferred, 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.
PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers.
• The employee must be able to lift 10 pounds per job requirement.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
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