[Remote] Principal Scientist, Biocompatibility at GE Healthcare

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical TechnologyIndustries

Requirements

Masters in physical/organic/biochemistry, toxicology, bioengineering, or 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 conducting material and chemical characterization of medical devices, physicochemical analyses of polymeric materials, metals, and ceramics
Experience (10+ years) in design and development of medical devices that are categorized as FDA Class II and Class III
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

Responsibilities

Serve as a lead scientist 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
Interface with Patient Care Solutions leadership in advising, developing, and conducting biocompatibility risk assessments, as a key voice in developing product strategy
Ensure standardized 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

Skills

Biocompatibility

Medical Devices

ISO 10993

Toxicology

Cytotoxicity

Systemic Toxicity

Genotoxicity

Risk Assessment

Material Selection

Test Methods

Standards Compliance

Regulatory Affairs

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees