Senior Medical Device Toxicologist

Boston Scientific; Arden Hills (MN); Hybrid; USD 78,000 - 149,000; Full time

Job summary

Boston Scientific in Arden Hills, MN is seeking a Medical Device Toxicologist III to provide technical support for biocompatibility and toxicology, contributing to biological evaluation and risk assessments for new product development and regulatory submissions.

The role emphasizes applying procedures and risk-based approaches to patient safety and product quality, with collaboration across teams and guidance on test plans and reports.

Qualifications

• Bachelor's degree in toxicology or a closely related field.
• Minimum of 3 years' experience in a related field.
• Knowledge of the biological evaluation of medical devices and/or drug-device combination products.

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 elevate complex or unprecedented matters as appropriate.

Skills

Biocompatibility knowledge

Toxicology assessment

Regulatory awareness

Education

Bachelor's degree in toxicology or related field

Job description

Boston Scientific in Arden Hills, MN is seeking a Medical Device Toxicologist III to provide technical support for biocompatibility and toxicology, contributing to biological evaluation and risk assessments for new product development and regulatory submissions.

The role emphasizes applying procedures and risk-based approaches to patient safety and product quality, with collaboration across teams and guidance on test plans and reports.