Job Description

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.The toxicologist will establish and maintain a biological evaluation program that integrates risk management. The 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. The toxicologist interacts with cross-functional members from R&D, Manufacturing, Purchasing, Planning, Quality Assurance, and Regulatory Affairs during product development activities. The toxicologist will improve the biological evaluation process using databases, information systems, and training programs. POSITION RESPONSIBILITIES: Responsibilities may include the following and other duties may be assigned. . Provide biological safety assessment to achieve ISO 10993 compliance and to support product development activities. . Provide 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, or Toxikon as appropriate. Is the primary interface between MDT and external/internal service providers. . 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: 0% BASIC QUALIFICATIONS: To be considered for this role, please ensure the minimum requirements are evident on your resume. . Bachelor\'s degree in a science or technic al field with 2+ years of work experience in biocompatibility and/or toxicology OR advanced degree in a science or technical field with 2+ years of work experience in biocompatibility and/or toxicology. EDUCATION REQUIRED: . Bachelor\'s degree YEARS OF EXPERIENCE Bachelor\'s degree with 1 to 10 years of experience. Masters Degree with 3+ years of experience in toxicology, physiology, or related discipline. Also, High speed broadband internet in must have SPECIALIZED KNOWLEDGE REQUIRED Nice to have: . . Master of Science degree 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. . 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. . Able to perform toxicological risk assessments. . Computer proficiency using word processors, spreadsheet, project management, and statistical software programs is required. PREFERRED QUALIFICATIONS . Master\'s degree preferred. . 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. . Requires strong problem solving and analytical skills. . Computer proficiency using word processors, spreadsheet, project management, and statistical software programs is required. . Able to apply advanced scientific principles. . Strong oral and written communication skills . Excellent presentation skills. . Must be able to handle multiple tasks/projects and manage priorities accordingly. . Must be able to work in a team environment, including cross-functional teams, and exert influence without alienating others. . Unimpeachable integrity. . A sense of humor. 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 with good sence of humour.

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