Principal Scientist, Biocompatibility
GE HealthcareSalary not specified
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries
Requirements
- Provide strategic leadership and scientific direction for the global biocompatibility and materials safety program supporting medical devices and combination products
- Lead teams of scientists and toxicologists to ensure compliance with international biocompatibility, extractables and leachables, and materials characterization standards
- Serve as the company’s subject matter expert and key liaison with regulatory agencies, internal stakeholders, and external partners on biological evaluation and materials safety
- Located in Santa Clara, CA or Saint Paul, Minnesota
Responsibilities
- Develop and execute the global biocompatibility strategy aligned with business and regulatory objectives
- Provide scientific and regulatory leadership on biological safety and toxicological risk assessment for materials, manufacturing processes, and finished products
- Integrate biocompatibility considerations early in product design, development, and lifecycle management
- Lead and mentor teams of biocompatibility scientists across multiple sites
- Foster a culture of collaboration, accountability, and continuous improvement
- Oversee capacity planning, resource allocation, and performance management within the biocompatibility organization
- Ensure compliance with ISO 10993 and applicable global regulatory guidance
- Provide expert input for regulatory submissions (IDE, PMA, 510(k), CE, NMPA, etc.) and represent the function during audits and agency interactions
- Maintain strong awareness of evolving global biocompatibility and toxicology regulations and guide the organization in adapting accordingly
- Oversee biological evaluation plans, toxicological risk assessments, and testing strategies for medical devices and combination products
- Collaborate closely with R&D, Quality, Regulatory, and Manufacturing to ensure material and process changes are biologically safe
- Guide biological evaluation programs for complex devices and combination products
- Partner with materials science, chemistry, and analytical testing teams to establish integrated strategies for material characterization and safety
- Serve as a key advisor to product development teams to enable safe, compliant, and efficient product launches
- Engage with external experts and standards organizations
Skills
Biocompatibility
Materials Safety
Extractables and Leachables
Toxicology
Biological Safety Evaluation
Regulatory Compliance
Medical Devices
Combination Products
Materials Characterization
Abbott
Healthcare solutions in diagnostics and devices
About Abbott
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.
Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees
