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ZOLL Medical Corporation · 1 week ago
Principal Biocompatibility Engineer
Chelmsford, MA
Full-time
Hybrid
Senior Level
10+ years exp
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Health CareMedical Device
Insider Connection @ZOLL Medical Corporation
Responsibilities
Lead the development of biological safety test strategies and plans for products, whether for new products or product updates/changes.
Apply deep technical expertise to lead and 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.
Represent the organization as the primary project and technical point of contact on external biocompatibility engagements.
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.
Lead the creation and defense of the biocompatibility elements of submissions to global regulatory authorities.
Review, interpret, and summarize data from reports and documents and biological risk assessments using sound scientific principles.
Ensure that testing meets international and domestic biocompatibility test requirements according to ISO, Good Laboratory Practices (GLP), FDA, EU MDR, Japan, and APAC countries.
Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
Support regulatory authority audits for products that may be sold globally.
Manage biocompatibility assessment documents for each product in ZOLL’s electronic document control system.
Qualification
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Required
BS and MS required in materials science, chemistry, biochemistry, biomedical engineering or similar field; PhD preferred
Ten or more years of biocompatibility of materials related experience including biomaterials, materials science, polymer chemistry and/or analytical chemistry
Demonstrated research and/or commercial experience in medical device biocompatibility that includes successful initiation and completion of complex biocompatibility projects
Functional expert in the principles of material science and in biocompatibility risk assessment for medical devices
Experience in technical leadership of biocompatibility projects from initiation to completion
Expert in US and global regulations (e.g., EU, China, Korea, and Japan) and requirements 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
Experience in polymer chemistry preferred
A detailed understanding of the medical device product development process is 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
Company data provided by crunchbase
