Job Description Summary

The Scientist Biocompatibility functions as a key team member by energetically supporting the goals of Depuy Synthes Toxicology & Biocompatibility. The Scientist collaborates with associates of diverse technical backgrounds and efficiently executes the biological safety evaluation of medical device products as per internal procedures and global standards and regulations. This personis responsible for planning and execution ofin vitro andin vivo biocompatibility evaluations andensures that products meet the requirements of biological safety according to relevant standards and regulations.

DUTIES & RESPONSIBILITIES

• Evaluates DePuy Synthes medical device products and materials for biological safety per international medical device regulations and standards, GLP (Good Laboratory Practice) guidelines and internal procedures.

• Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for MD materials and products.

• Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.

• Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables.

• Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion.

• Interacts closely with and provides technical guidance andexpertiseto internal stakeholders (e.g., R&D, Clinical Affairs, Regulatory Affairs, Manufacturing, Quality Engineering, and Supplier Management)

• Can support regulatory/notified body requests as part of Audits and File/Product submissions/Reviews in applicable markets.

• Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools.

• Identifies and evaluates potential risks and drives resolution with team members, peers, PMO and management.

• Participates in continuous improvement activities and actively participates in shaping processes and procedures

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• Bachelors or mastersdegree in biology, chemistry, toxicology, microbiology, biomedical engineering, or a related scientificdisciplinewith a minimum of2years ofindustrialexperiencein biocompatibility evaluation,or PhD withat least 1year ofindustrialexperiencein biocompatibility evaluation

• A minimum 1-2 years of experience in biocompatibility assessment and evaluation in a medical device, pharmaceutical, and/or consumer product company or similar combination of professional training and multi-year experience in the industry.

• Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.

• Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements

• Understanding of manufacturing processes of medical devices is preferred.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: