Medical Device Toxicologist III

About the role: 

The Medical Device Toxicologist III at Boston Scientific provides technical support for biocompatibility and toxicology processes to meet global business objectives. This position contributes to the biological evaluation of medical devices in support of new product development, sustaining activities, and global regulatory submissions. Additionally, this position may include the conduct of toxicological risk assessments based on data derived from extractables and leachables studies. The role applies established standards, procedures, and risk-based approaches to help ensure patient safety and product quality while enabling timely product development and regulatory decisions. 

Your responsibilities will include:

• Providing support for biocompatibility processes initiated by department management and ensuring biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements.

• Demonstration of a primary commitment to patient safety and product quality.

• Authoring biocompatibility and chemical characterization test plans, authoring biocompatibility assessments and reports, and assessing test data and reports as necessary to support business objectives.

• Authoring or assisting to author toxicological risk assessments, as assigned, to support divisional objectives.

• Providing informal guidance to new or less-experienced team members on established biocompatibility and chemical characterization processes, as appropriate.

• Maintenance of communication with internal customers on biocompatibility and toxicology issues, and supporting the resolution of straightforward to moderately complex issues related to biological evaluation, chemical characterization, and toxicological risk assessment. 

• Consulting on biocompatibility, chemistry and toxicology testing and strategies related to new investigational and strategic 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.

• Participating, as assigned, in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements.

• Serving 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. 

• Advising on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs; identifying issues and escalating complex or unprecedented matters as appropriate.    

 
Required qualifications:

• An Honours Degree (Level 8) in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering).

• 3-5 years of related medical device / related industry experience.

• Knowledge of the biological evaluation of medical devices and / or drug-device combination products.

 
Preferred qualifications:

• A Masters degree (Level 9) in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with an Masters (Level 9) and 2+ years of related experience.

• A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with an PhD and 1+ years of related experience.

• Applied knowledge and understanding 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 with respect to medical device and combination products.

• Experience supporting GLP and nGLP studies

• Excellent written and verbal communication skills. 

• Results and detail-oriented 

• Able to multi-task while working against aggressive timelines. 

• Comfortable in a dynamic environment and able to work with a moderate level of guidance, independently on assigned work, and collaboratively on teams.