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ZOLL Medical Corporation · 2 days ago
Senior Biocompatibility Engineer
Chelmsford, MA
Full-time
Hybrid
Senior Level
5+ years exp
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Responsibilities
Apply technical expertise to perform complex biomaterials and biocompatibility analyses related to global biocompatibility standards and regulatory authority requirements for product biological safety.
Plan, manage, and perform assessments of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components to ensure biological safety and product sustainability.
Provide materials and biocompatibility assessments, strategies, and deliverables in compliance with global regulatory requirements such as ISO 10993 and ISO 18562.
Identify and assess business/technical project risks and recommend/influence approaches.
Support the creation and defense of submissions to global regulatory authorities.
Collaborate and clearly communicate with internal and external stakeholders (e.g., consultants, testing labs, board certified toxicologists and contract research organizations) to ensure appropriate planning and execution of risk assessments and required testing.
Review, interpret, and summarize data from external stakeholders on reports and documents and biological risk assessments using sound scientific principles.
Ensure that testing meets international and domestic biocompatibility test requirements according to ISO, FDA, EU MDR, GLP, Japan, and APAC countries.
Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
Support on-site and off-site regulatory authority audits for products that may be sold globally.
Manage biocompatibility assessment documents for each product in ZOLL’s electronic document control system. Ensure the assessment documents are in accordance with the latest version of the standards, where applicable.
Qualification
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Required
Bachelor’s and master’s degrees in materials science, chemistry, biochemistry, or biomedical engineering with five or more years of biocompatibility of materials related experience or a PhD degree in a similar discipline with research experience in biocompatibility of materials, biomaterials, materials science, polymer chemistry and/or analytical chemistry.
Functional expert in the principles of material science and in biocompatibility risk assessment for medical devices.
Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements Job Profile: Senior Biocompatibility Engineer for biocompatibility testing, particularly ISO 10993 and ISO 18562.
Knowledgeable of applicable ASTM, ISO, FDA, EN, Japan, and APAC standards with an in-depth understanding of ISO 10993 and ISO 18562 biocompatibility standards.
Knowledgeable of relevant sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA guidance documents (e.g., Threshold of Toxicological Concern and use of ISO 10993-1, etc.)
Preferred
Detailed understanding of the product development process is preferred
Experience scoping and managing projects, determine impact of decisions and balance priorities and deliverables.
Effective relationship management with internal and external stakeholders.
Proficient with statistics and the Microsoft suite of office applications.
Demonstrated research and/or commercial experience in medical device biocompatibility is preferred; publication in peer review journals is also preferred. Experience in polymer chemistry and pre-clinical science/biocompatibility testing in medical devices also preferred
Company
ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies.
1,001-5,000 employees
H1B Sponsorship
ZOLL Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (5)
2022 (9)
2021 (4)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Jon Rennert
CEO
Aaron Grossman
Chief Legal Officer
Recent News
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