Job Description Summary

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 in the GE HealthCare Imaging/ X-ray/ CT 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:

• 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.

Required Qualifications:

• 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.

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, 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.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information