Biocompatibility Scientist at GE Healthcare

Beijing, Beijing, China

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Medical ImagingIndustries

Requirements

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

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 up to date on regulatory requirements and assess the impact of new standards and/or regulations to enable the generation of appropriate strategies for biocompatibility work

Skills

Biocompatibility

ISO 10993

21CFR58 GLP

Biological Evaluation

Toxicological Principles

Hazard Analysis

Risk Analysis

Medical Devices

Regulatory Compliance

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

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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