Vacancy expired!
Title: Senior Toxicologist/Sr. Scientist - 100% Remote Location: Brooklyn Park, MN, 55428 Duration: 12 months Top 3 skills needed: style="font-family:"Times New Roman"; font-size:medium" Technical expertise in ISO 10993 and toxicological risk assessments, effective communication, and organization style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" Candidate can be fully remote anywhere in the US. style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" POSITION DESCRIPTION: style="font-family:"Times New Roman"; font-size:medium" 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. style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" POSITION RESPONSIBILITIES: style="font-family:"Times New Roman"; font-size:medium" Provides biological safety assessment to achieve ISO 10993 compliance and to support product development activities. style="font-family:"Times New Roman"; font-size:medium" 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. style="font-family:"Times New Roman"; font-size:medium" 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. style="font-family:"Times New Roman"; font-size:medium" Establishes and integrates risk management process as part of the biological evaluation program in a manner that complies with ISO 10993. style="font-family:"Times New Roman"; font-size:medium" Assesses the biological safety impact from manufacturing and supplier changes on patient-contacting devices. style="font-family:"Times New Roman"; font-size:medium" Consults on the biological safety impact from device field issues. style="font-family:"Times New Roman"; font-size:medium" Develops or identifies resources and provides training to aid product development activities with biological evaluation process. (Web-based biomaterials support, biomaterials testing databases). style="font-family:"Times New Roman"; font-size:medium" Mentors engineers. style="font-family:"Times New Roman"; font-size:medium" All activities must be performed in compliance with the Quality System. style="font-family:"Times New Roman"; font-size:medium" Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations. style="font-family:"Times New Roman"; font-size:medium" All other duties as assigned. style="font-family:"Times New Roman"; font-size:medium" Travel requirement: Less than 10% style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" BASIC QUALIFICATIONS: style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" EDUCATION REQUIRED: style="font-family:"Times New Roman"; font-size:medium" Bachelor of Science degree required. style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" YEARS OF EXPERIENCE style="font-family:"Times New Roman"; font-size:medium" 5+ years of experience in the medical device or pharmaceutical industry performing or overseeing biological safety assessments, related risk assessments, and or equivalent experience. style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" SPECIALIZED KNOWLEDGE REQUIRED style="font-family:"Times New Roman"; font-size:medium" In-depth knowledge of biological impact of foreign materials in the human body. style="font-family:"Times New Roman"; font-size:medium" Knowledge of applicable ASTM, ISO, FDA and EN standards. An in-depth understanding of ISO 10993 Biocompatibility standard. style="font-family:"Times New Roman"; font-size:medium" Computer proficiency using word processors, spreadsheet, project management, and statistical software programs is required. style="font-family:"Times New Roman"; font-size:medium" style="font-family:"Times New Roman"; font-size:medium" PREFERRED QUALIFICATIONS style="font-family:"Times New Roman"; font-size:medium" Master of Science or PhD in toxicology, physiology, or related discipline preferred. style="font-family:"Times New Roman"; font-size:medium" Strong problem solving and analytical skills. style="font-family:"Times New Roman"; font-size:medium" Able to apply advanced scientific principles. style="font-family:"Times New Roman"; font-size:medium" Good oral and written communication skills. style="font-family:"Times New Roman"; font-size:medium" Excellent presentation skills. style="font-family:"Times New Roman"; font-size:medium" Able to handle multiple tasks/projects and manage priorities accordingly. style="font-family:"Times New Roman"; font-size:medium" Able to work in a team environment, including cross-functional teams, and exert influence without alienating others.
Vacancy expired!