Medical Device Toxicologist III

About the role

The Medical Device Toxicologist III at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. This position contributes to the biological evaluation of medical device products, including toxicological risk assessments based on data from extractables and leachables studies, in support of new product development, sustaining activities and global regulatory submissions.

Responsibilities

• Support biocompatibility and toxicology processes initiated by department management and help ensure related information and data are accurate, reliable and aligned with Global Preclinical objectives and Quality Management System requirements.
• Demonstrate a primary commitment to patient safety and product quality.
• Author biocompatibility and chemical characterization test plans, biocompatibility assessments and reports, and assess test data and reports as assigned to support business objectives.
• Author toxicological risk assessments as assigned to support divisional objectives, applying established procedures, precedents and scientific judgment.
• Provide informal guidance to new or less-experienced team members on established biocompatibility and chemical characterization processes, as appropriate.
• Maintain communication with internal customers on biocompatibility and toxicology topics and support the resolution of straightforward to moderately complex issues related to biological evaluation, chemical characterization and toxicological risk assessment.
• Support biocompatibility, chemistry and toxicology testing strategies for assigned investigational and device development programs during technology and product development programs (TDP/PDP).
• Apply working knowledge of regulatory requirements and internal procedures to support medical device submissions for assigned projects and divisions, with guidance on complex or unprecedented issues.
• Participate, as assigned, in biocompatibility training for device development teams based on applicable standards, procedures and regulatory requirements.
• Serve as a resource for factual biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include materials of animal origin, color additives, chemical exposure assessments and other chemical toxicities.
• Apply established procedures, techniques, concepts and approaches to assigned biocompatibility and toxicology programs; identify issues and escalate complex or unprecedented matters as appropriate.

Qualifications

• Required qualifications: Bachelor's degree in toxicology or a closely related field, such as biology, chemistry, biochemistry or biomedical engineering. Minimum of 3 years' experience in a related field. Knowledge of the biological evaluation of medical devices and/or drug-device combination products.
• PREFERRED QUALIFICATIONS: Master's degree in toxicology or a closely related field, such as biology, chemistry, biochemistry or biomedical engineering. Candidates with a master's degree and a minimum of 1 year's related experience will be considered. Doctoral degree in toxicology or a related field, such as biology, chemistry, biochemistry or biomedical engineering. Solid knowledge and practical application of toxicology principles and best practices. Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials. Working knowledge of regulatory standards and global regulatory requirements for medical devices and combination products. Experience supporting GLP and non-GLP studies. Excellent written and verbal communication skills. Results-oriented and detail-oriented approach. Ability to manage multiple assignments and priorities while meeting project timelines. Ability to work effectively in a dynamic environment with a moderate level of guidance, independently on assigned work and collaboratively as part of a team.