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:
Performs within the requirements of the Medtronic site Quality System.
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 Toxocologist 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, Apptec, or Toxicon 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%
BASIC QUALIFICATIONS:
EDUCATION REQUIRED:
Bachelor\xe2\x80\x99s degree
YEARS OF EXPERIENCE
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