Senior Medical Device Toxicologist

4 weeks ago

Marlborough, United States Boston Scientific Full time

Work mode: Hybrid

Onsite Location(s):

Marlborough, MA, US, 01752


Additional Location(s): US-MN-Arden Hills; US-MN-Maple Grove.

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance


At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


About the role:

The Senior Medical Device Toxicologist at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. Additionally, this position is responsible for the biological evaluation of medical device products, including the conduct of toxicological risk assessments based on data derived from extractables and leachables studies, in support of new product development and sustaining activities, as well as in support of global regulatory submissions. Global Toxicology and Biocompatibility plays a critical role in medical device development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization.

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist

Your responsibilities will include:

  • Provide support for biocompatibility processes initiated by department management and ensure 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.
  • Demonstrate a primary commitment to patient safety and product quality.
  • Responsible for authoring biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports as necessary to support business objectives.
  • Responsible for authoring toxicological risk assessments as assigned to support divisional objectives.
  • Responsible for advising more junior staff on the development of Biocompatibility and chemical characterization test plans, reviewing and approving Biocompatibility Assessments and Reports, and assessing test data and reports as necessary to support business objectives, including authoring such reports as necessary.
  • Maintains communications with internal customers on biocompatibility and toxicology issues, support problem solving and resolution related to related to biocompatibility assessments, chemical characterization, and toxicological risk assessments
  • Consults 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).
  • Provides consultation on regulatory requirements related to medical device submissions for assigned divisions and in support of corporate initiatives.
  • Participates as assigned in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements.
  • May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities.
  • Advises on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs.

Required qualifications:

  • Minimum Bachelor's degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering)
  • Minimum 5 years of related experience.
  • Knowledge of the biological evaluation of medical devices and/or drug-device combination products.

Preferred qualifications:

  • Master's degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Preferred Masters and 3+ years of related experience
  • PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Preferred 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
  • Prior experience with running GLP and non GLP studies

  • Senior Medical Device Toxicologist

    2 weeks ago

    Marlborough, Massachusetts, United States Boston Scientific Full time

    Job Title: Senior Medical Device ToxicologistJoin Boston Scientific as a Senior Medical Device Toxicologist and contribute to the development of innovative medical devices that improve patient outcomes.About the Role:The Senior Medical Device Toxicologist will provide technical support for toxicology and biocompatibility processes to meet global business...

  • Senior Lab Technician

    1 week ago

    Marlborough, Massachusetts, United States The Fountain Group Full time

    Job SummaryWe are seeking a highly skilled Senior Lab Technician to join our team at The Fountain Group. As a Senior Lab Technician, you will play a key role in the design and organization of experiments, working closely with the Tech Lead and R&D Team members. Your expertise will be essential in developing hands-on tests of new products, including the...

  • Medical Device Development Specialist

    2 weeks ago

    Marlborough, Massachusetts, United States Belcan Full time

    Job Title: Medical Device Development SpecialistBelcan is seeking a highly skilled Medical Device Development Specialist to join our team in Marlborough, MA. As a key member of our team, you will be responsible for designing and developing medical devices, ensuring compliance with FDA regulations and industry standards.Key Responsibilities:Design and develop...

  • NPI Engineer

    2 weeks ago

    Marlborough, Massachusetts, United States Michael Page Full time

    About Our ClientA leading medical device design and manufacturing organization with a strong track record of innovation and customer service.Job DescriptionThe NPI Engineer will be responsible for designing and improving device assembly efficiency, validating and qualifying medical devices, and identifying and optimizing production processes.Key...

  • Laser Medical Device Technician

    2 months ago

    Marlborough, Massachusetts, United States IPG Photonics Full time

    About IPG MedicalIPG Medical, a subsidiary of IPG Photonics, is a leading developer of innovative medical device laser solutions. Our mission is to improve lives through the application of light-based technologies.Job SummaryWe are seeking a skilled Laser Medical Device Technician to join our team. As a key member of our production team, you will be...

  • Project Engineer for Medical Devices

    4 days ago

    Marlborough, Massachusetts, United States Helen of Troy Full time

    Project Engineer for Medical DevicesAt Helen of Troy, we are seeking a skilled Project Engineer to lead the development of consumer medical products. As a key member of our Engineering team, you will be responsible for designing, developing, and evaluating medical devices to ensure they meet regulatory requirements and customer needs.Key...

  • Medical Device Lab Technician

    1 month ago

    Marlborough, Massachusetts, United States Advantage Technical Full time

    Job Title: Medical Device Laboratory Support SpecialistWe are seeking a highly skilled Medical Device Laboratory Support Specialist to join our team at Advantage Technical. As a Medical Device Laboratory Support Specialist, you will be responsible for providing daily operational support to our laboratory, ensuring compliance with safety regulations, and...

  • Senior Medical Engineer

    1 week ago

    Marlborough, Massachusetts, United States Inova Health System Full time

    We are seeking a Senior Medical Engineer to join our team in a full-time capacity. In this role, you will play a critical part in designing, documenting, and verifying Electronic Systems used in medical laser technology.Responsibilities:Design, implement, and test analog/digital PCBs for new medical products and enhance existing features.Lead advanced...

  • Sr. Quality Engineer

    3 days ago

    Marlborough, United States The Judge Group Full time

    Our client is currently seeking a Sr. Quality Engineer - Medical Device/ON SITE position***All candidates must live in the Metro-Boston & Rhode Island area***Responsibilities:Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issuesAssist with maintenance of calibration...

  • NPI Engineer- Medical Device- Marlborough, MA

    6 days ago

    Marlborough, United States Michael Page Full time

    The NPI Engineer will be a key player in the development of essential medical device products through design development into manufacturing through the entire product life cycle phase. Client DetailsA nationally recognized medical device design and manufacturing organization. In 2024 they have continued to acquire several new organizations nationally with...

  • Medical Devices Project Lead

    5 days ago

    Marlborough, Massachusetts, United States Helen of Troy Full time

    Project Engineer, Medical DevicesWe are seeking a highly skilled Project Engineer to lead the design, development, and evaluation of consumer medical products. This role will be responsible for developing verification and validation methods to ensure products meet intended use and specification needs.The successful candidate will have a strong background in...

  • Sr. Opto-Mechanical Engineer

    3 days ago

    Marlborough, United States The Judge Group Full time

    The Judge Group is currently seeking a Sr. Opto-Mechanical Engineer with medical Device experience for a full time opportunity.This role requires expertise in system and optics packaging, medical product design, innovative design solutions, and mechanical analysis.Location: Marlborough, MA - Fully OnsiteType: Full Time PermanentKey Responsibilities:Lead...

  • Project Engineer Medical Devices

    3 weeks ago

    Marlborough, Massachusetts, United States 327 Health & Home USA, Inc. Full time

    Project Engineer Medical DevicesWe are seeking a highly skilled Project Engineer to join our team at Helen of Troy. As a Project Engineer, you will be responsible for leading the technical development of consumer medical products, ensuring they meet regulatory requirements and customer needs.Key Responsibilities:Lead the technical development of consumer...

  • Senior Systems Engineer

    1 month ago

    Marlborough, Massachusetts, United States Candela Medical Full time

    Senior/Principal Systems Engineer Job OpportunityCandela Medical is seeking a highly skilled Senior/Principal Systems Engineer to lead the development and implementation of aesthetic laser systems and accessories. This is a senior-level engineering position responsible for defining, architecting, and coordinating the implementation of engineering tasks...

  • Project Engineering Manager Medical Devices

    4 days ago

    Marlborough, Massachusetts, United States Helen of Troy Full time

    As a Project Engineer at Helen of Troy, you will be responsible for leading the technical and program aspects of design, development, and evaluation of consumer medical products.This role involves developing verification and validation methods for medical products to ensure they meet intended use and specification needs.You will also be responsible for...

  • Senior Chemical Process Engineer

    3 weeks ago

    Marlborough, Massachusetts, United States Michael Page Full time

    About Our ClientA leading medical device manufacturer based in New England, with multiple locations across the Northeast, specializes in developing disposable medical device products through development and production.Job DescriptionThe Senior Chemical Engineer will be responsible for leading formulation development, supporting the technical chemical...

  • Senior Chemical Engineer- Marlborough, MA

    6 days ago

    Marlborough, United States Michael Page Full time

    The Senior Chemical Engineer will be a lead development engineer with specific formulation processes as part of their medical device manufacturing projects. Client DetailsA New England based medical device manufacturer with several locations across the Northeast developing disposable medical device products through development and production. DescriptionThe...

  • Sales Operations Analyst

    4 days ago

    Marlborough, Massachusetts, United States Pharmavise Corporation Full time

    Job Role: Sales Operations Analyst – Medical DevicePharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. We are seeking a highly skilled Sales Operations Analyst to join our team.Job Summary:The Sales Operations Analyst is responsible for providing sales reporting...

  • Senior Chemical Engineer- Marlborough, MA

    2 weeks ago

    Marlborough, Massachusetts, United States Michael Page Full time

    About Our ClientA leading medical device manufacturer based in New England, with multiple locations across the Northeast, specializes in developing disposable medical device products through development and production.Job DescriptionThe Senior Chemical Engineer will be responsible for leading formulation development, supporting the technical chemical...

  • Senior Laboratory Technician

    2 weeks ago

    Marlborough, Massachusetts, United States Belcan Full time

    Job Title: Senior Laboratory TechnicianBelcan is seeking a highly skilled Senior Laboratory Technician to join our team. As a key member of our laboratory operations team, you will be responsible for designing and organizing experiments, developing test methods, and verifying design specifications of new products.Key Responsibilities:Participate in the...