Interested in being a hands on in developing a center of excellence for Toxicology within a stable fortune 500 medical device company? This is a great opportunity to come in and define how this company does Toxicology, Biocompatibility and optimization of products for patients. Building this department from the ground up will provide a ton of opportunity for you to utilize your past experience and knowledge to create something better than ever before!
In this exciting role as a Senior Toxiocologist, you will have primary focus 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.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
BRAIN THERAPIES offers an integrated portfolio of devices
and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
A Day in the Life
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, WuXiAppTec, 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).
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%
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor of Science degree required.
YEARS OF EXPERIENCE
4+ years of experience in the medical device or pharmaceutical industry performing or overseeing biological safety assessments, related risk assessments, and or equivalent experience.
2+ years of experience with an Advanced Degree
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 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.