Scientist II - Biocompatibility

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that address serious health issues today and the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience, and products and services in our Allergan Aesthetics portfolio.

The Scientist II – Biocompatibility is a subject matter expert who will provide highly skilled support for biocompatibility and non‑clinical safety evaluations of medical devices, tissue products, and combination products as part of Abb Vie Research & Development. The role involves supporting cross‑functional collaborations, establishing requirements, planning, execution, and approval of biocompatibility activities, and providing recommendations for biocompatibility activities with limited supervision.

• Serve as a representative for ISO‑10993 (biocompatibility) assessments, design, execute, and interpret biocompatibility evaluation strategies and programs per regulatory requirements.
• Support project plans for biocompatibility with realistic deliverables and timelines, and be actively involved in planning, execution, and management of experimental studies for safety and efficacy characterization of new and existing products.
• Act as the dedicated biocompatibility resource for product development teams, providing technical knowledge to support cross‑functional project initiatives.
• Maintain knowledge of medical device regulations and ensure compliance, performing gap analysis relevant to changes in biocompatibility standards or guidance, and updating internal product files for component or process changes.
• Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision, and assist the team in functional training initiatives.
• Support global change control activities related to Biocompatibility.
• Build and maintain strong connections with contract research organizations, toxicologists, and consultants for biological risk assessments as needed.

• Bachelor’s degree in Life Science, Biomedical Engineering, or a related field with a minimum of 7 years of experience in a scientific role within the medical device or pharmaceutical industry, or a Master’s degree with at least 5 years of experience.
• Experience supporting patient safety studies in an R&D context and a proven record of success in a regulated environment.
• Knowledge of medical device and combination product regulations, ISO‑10993 standards, FDA guidance, and animal welfare regulations.
• Strong technical writing and verbal communication skills.
• Self‑motivated with the ability to execute with minimal supervision, working independently or as part of a team, and under a sense of urgency for priority projects.
• Ability to communicate complex technical information clearly in both verbal and written formats.
• Familiarity with the product development process for medical devices or biologics.
• Demonstrated critical thinking and problem‑solving skills, including data analysis and presentation.
• Knowledge of Good Documentation Practices, maintaining accurate documentation, and record retention.
• Knowledge of Good Laboratory Practices (21 CFR, Part 58) and ISO‑10993 standards.

• Compensation:
  The compensation range is a range of possible base pay the Company believes in good faith it will pay for this role at the time of posting, and may be modified in the future.
• Benefits:
  We offer a comprehensive package of paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan to eligible employees.
• Participation:
  This job is eligible to participate in our short‑term incentive programs.

Legal EEO Statement

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled / US & Puerto Rico only – for more information, visit  Applicants seeking a reasonable accommodation may  to learn more: