GE HealthCare · 4 months ago
Biocompatibility Scientist
Waukesha
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expGE HealthCare is a leading global medical technology and digital solutions innovator. In this role, you will be a leading Scientist focused on defining and executing innovative strategies for biocompatibility evaluation and risk analysis of medical devices, ensuring compliance with standards and regulations while supporting product development.
AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical
Responsibilities
Design and execute medical device biocompatibility strategies to assure user and patient safety through the application of current biological evaluation and toxicological principles in support of new product development and sustaining activities
Standardize test methods across multiple material and device types, leveraging common data to derive meaningful conclusions on the potential for biocompatibility concern
Lead and author Biocompatibility deliverables – e.g., biological evaluation plan & reports, hazard analysis, white paper, technical memo, and other relevant activities in support of global programs
Implement the use of ISO 10993 series, 21CFR58 GLP for non-clinical studies, and/ or other regulatory guidance documents to qualify GE Healthcare products
Provide technical and strategic input to meet business objectives at the project team level while assuring compliance with GE Healthcare and external standards
Interpret raw material, finished device data, and literature to assess overall risk to patient
Develop justification to address ISO 10993 – 1 endpoints based on study data and literature
Independently review literature and identify relevant information to support product development and registration
As needed – engage in standards organization and/ or regulatory committees to ensure emerging regulations are based on well-established science and toxicological principles
Keep upto date on regulatory requirements and assess the impact of new standards and/or regulations to enable the generation of appropriate strategies for biocompatibility work
Qualification
Required
PhD in physical/organic/biochemistry, toxicology, material science, bioengineering, or an equivalent scientific field
Expert knowledge in use and application of ISO 10993 series of standards
Experience (10+ years) in design and development of medical devices that are categorized as FDA Class I, II and Class III
Experience conducting material and chemical characterization of medical devices, physicochemical analyses of polymeric materials, metals, and ceramics
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements
Advanced experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications
Preferred
American Board of Toxicology Diplomate (DABT), or other national equivalent such as ERT
Experience leading test lab operations that support medical device biocompatibility evaluations
Experience in mechanical design (15+ years)
Experience as a lead convenor of a Technical Committee (TC) or Working Group (WG) of a Standards Development Organization (SDO) or National Standards Body (NSB) such as ISO, ANSI, or AAMI
Experience preparing communications for and interacting with multiple regulatory bodies world-wide such as FDA, NMPA, TGA, MHLW, PMDA, CDSCO, BfArM, ANSM, etc
Experience with high risk, life supporting, and life-sustaining products
Demonstrated life-long learner; eagerness to obtain new skills and knowledge
Humility in understanding, but assertive when needed; willing to make decisions and assign clear priorities
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems
Benefits
Relocation Assistance Provided
Company
GE HealthCare
GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.
10001+ employees
H1B Sponsorship
GE HealthCare 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
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2021 (1)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$5.52BKey Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B
Leadership Team
Catherine Estrampes
President and CEO, US & Canada
Luiz Verzegnassi
President & CEO, Services
Recent News
eeNews Europe
2026-01-09
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