Boston Scientific Gruppe
Medical Device Toxicologist II
Boston Scientific Gruppe, Saint Paul, Minnesota, United States, 55199
Overview
The Medical Device Toxicologist II at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. This role involves the biological evaluation of medical device products in accordance with ISO 10993, in support of new product development and sustaining activities (e.g., manufacturing and engineering changes) and regulatory submissions. Global Toxicology and Biocompatibility supports patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization. Work Mode:
This role follows a hybrid work model requiring employees to be in the local office at least three days per week. Relocation/ sponsorship:
Relocation assistance is not available and Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Responsibilities
Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology data are accurate, reliable, and support business objectives in line with Global Preclinical objectives and Quality Management System requirements. Demonstrate a primary commitment to patient safety and product quality. Under direction and mentorship of senior staff, complete biocompatibility evaluations and safety assessments to support business objectives. Provide input on regulatory requirements related to medical device submissions and on procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programs. May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, including issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities as assigned. Communicate with internal customers on biocompatibility and toxicology issues, support problem solving and resolution related to biocompatibility assessments, chemical characterization, and toxicological risk assessments. Participate in training for functional groups of device development teams based on standards and regulatory requirements. Provide input on biocompatibility, chemistry, and toxicology testing related to new investigational and strategic device development programs. Required qualifications
A BS / MS degree in Toxicology is preferred, or a closely related field (biology, chemistry, biochemistry, biomedical engineering). 2+ years’ experience supporting medical devices. Excellent written and verbal communication skills. Results- and detail-oriented with the ability to multi-task against aggressive timelines. Comfortable in a dynamic environment and able to work independently as well as on teams. Preferred Qualifications
Knowledge of the biological evaluation of medical devices (ISO 10993-1) preferred, including risk assessment methodologies and toxicological evaluation of medical device materials. Working knowledge of regulatory standards and global regulatory requirements for medical devices. Experience with running GLP and non-GLP studies. A BS / MS degree in Toxicology is preferred. Requisition ID:
613548 Salary range:
Minimum $69,500; Maximum $132,000 The anticipated compensation and benefits offered by Boston Scientific (see www.bscbenefitsconnect.com) vary by location and other factors. Compensation is commensurate with experience, education, and certifications. Boston Scientific is an equal opportunity employer. Boston Scientific is committed to a diverse and inclusive workplace and to equal employment opportunity. All personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, or any other protected class. This role is designated as safety-sensitive and may be subject to a prohibited substance test where permitted by law.
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The Medical Device Toxicologist II at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. This role involves the biological evaluation of medical device products in accordance with ISO 10993, in support of new product development and sustaining activities (e.g., manufacturing and engineering changes) and regulatory submissions. Global Toxicology and Biocompatibility supports patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization. Work Mode:
This role follows a hybrid work model requiring employees to be in the local office at least three days per week. Relocation/ sponsorship:
Relocation assistance is not available and Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Responsibilities
Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology data are accurate, reliable, and support business objectives in line with Global Preclinical objectives and Quality Management System requirements. Demonstrate a primary commitment to patient safety and product quality. Under direction and mentorship of senior staff, complete biocompatibility evaluations and safety assessments to support business objectives. Provide input on regulatory requirements related to medical device submissions and on procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programs. May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, including issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities as assigned. Communicate with internal customers on biocompatibility and toxicology issues, support problem solving and resolution related to biocompatibility assessments, chemical characterization, and toxicological risk assessments. Participate in training for functional groups of device development teams based on standards and regulatory requirements. Provide input on biocompatibility, chemistry, and toxicology testing related to new investigational and strategic device development programs. Required qualifications
A BS / MS degree in Toxicology is preferred, or a closely related field (biology, chemistry, biochemistry, biomedical engineering). 2+ years’ experience supporting medical devices. Excellent written and verbal communication skills. Results- and detail-oriented with the ability to multi-task against aggressive timelines. Comfortable in a dynamic environment and able to work independently as well as on teams. Preferred Qualifications
Knowledge of the biological evaluation of medical devices (ISO 10993-1) preferred, including risk assessment methodologies and toxicological evaluation of medical device materials. Working knowledge of regulatory standards and global regulatory requirements for medical devices. Experience with running GLP and non-GLP studies. A BS / MS degree in Toxicology is preferred. Requisition ID:
613548 Salary range:
Minimum $69,500; Maximum $132,000 The anticipated compensation and benefits offered by Boston Scientific (see www.bscbenefitsconnect.com) vary by location and other factors. Compensation is commensurate with experience, education, and certifications. Boston Scientific is an equal opportunity employer. Boston Scientific is committed to a diverse and inclusive workplace and to equal employment opportunity. All personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, or any other protected class. This role is designated as safety-sensitive and may be subject to a prohibited substance test where permitted by law.
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