Principal Scientist, Biocompatibility
Principal Scientist, Biocompatibility
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$ 173600 - 260400
1 Vacancy
Job Description
Job Description Summary
In this role you will be a leading Scientist and Engineer focused on enabling 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 implementing strategies for biocompatibility-related standards acting as one of GE HealthCares voice as policies develop and supporting 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:
- 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.
Required Qualifications:
- Masters 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 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 customers 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 (5 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.
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For U.S. based positions only the pay range for this position is $173600.00-$260400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and location. In addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. 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. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
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
Required Experience:
Staff IC
Employment Type
Full-Time
