Job Description Summary

　　In this role you will be a leading Scientist and Engineer focused on defining and executing innovative strategies for biocompatibility design and evaluation of medical devices in the GE HealthCare Patient Care Solutions family of businesses. This will include leading strategy for biocompatibility-related standards, acting as GE HealthCare’s voice as policies develop, and overseeing programs to ensure successful implementation internally and with external bodies such as standard organizations and regulatory authorities.

　　GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

　　Job Description

　　Roles and Responsibilities:

　　As the lead scientist and strategist for biocompatibility related standards, design requirements, test methods, and interpret test results for the PCS business across its sub-segments, for products such as patient monitors, anesthesia systems, cardiology/ECG, home care, maternal/infant care, and clinical accessories.

　　Act as the external interface for the PCS business with leading external biocompatibility research groups, standards organizations, and global regulatory bodies.

　　Interface with company leadership in advising, developing, and conducting biocompatibility risk assessments, as a key voice in developing product strategy.

　　Standardize test methods across multiple material and device types, leveraging common data to derive meaningful conclusions on the potential for toxicological concern.

　　Oversee technical approaches (material selections, design, test methods, test execution) for products to ensure they designed according to biocompatibility science and standards, and lead efforts to ensure existing products remain state-of-the-art with such science and standards.

　　Evaluate materials for potential cytotoxicity, systemic toxicity, genotoxicity, carcinogenicity, degradation, leachables, or off-gassing; and incorporate adequate requirements to ensure low risk of potential toxicological risk in plastics design guidelines and technical design reviews.

　　Required Qualifications:

　　PhD in physical/organic/biochemistry, toxicology, bioengineering, or and equivalent material science.

　　Expert in ISO 10993 (biological evaluation of medical devices) for surface contact materials and ISO 18562 (biocompatibility evaluation of breathing gas pathways).

　　Experience (10+ years) in design and development of medical devices that are categorized as FDA Class II and Class III.

　　Experience conducting material and chemical characterization of medical devices, physicochemical analyses of polymeric materials, metals, and ceramics.

　　Experience with residue analyses, biological evaluation, and toxicological risk assessment of medical devices with direct contact (physical contact with body tissue), indirect contact (fluid or gas pathways, prior to tissue contact), and transient contact (brief contact with body tissue); ability to design experiments for and derive thresholds of toxicological concern and tolerable exposure levels.

　　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.

　　Desired Characteristics:

　　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, IEC, IEEE, 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.

　　#LI-CH3

　　Additional Job Description

　　Additional Information

　　Compensation Grade

　　SPB1

　　GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunities Employer. (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

　　GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

　　While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

　　Relocation Assistance Provided: Yes