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GE HealthCare · 13 hours ago

Biocompatibility Scientist

Georgia, United States

Full-time

Onsite

Senior Level

6+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. The Biocompatibility Scientist will focus on defining and executing innovative strategies for biocompatibility evaluation and risk analysis of medical devices, ensuring compliance with standards and regulations while leading biocompatibility-related programs.

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Growth Opportunities

No H1B

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

ISO 10993 standardsMedical device designToxicologyMaterial characterizationRegulatory knowledgeBiochemistryBioengineeringMS Office proficiencyLife-long learnerCommunication skills

Required

Bachelors Degree with 10 + years OR Master degree with 8 + OR PhD with 6 + years experience 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

6 years experience 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

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

Benefits

Relocation Assistance Provided: Yes

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees