Biocompatibility Specialist II

Essential Duties And Responsibilities

• Develop and manage internal programs, with a global perspective, on biological safety risk assessment, toxicological risk assessments, testing plans / strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirement
• Participate in design review meetings as a key member of new product design teams to assess products for biocompatibility and related biological safety concerns, including documentation of biological safety assessments, test plans, and associated reports
• Actively represent Arthrex and the medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT
• Manage the appropriate maintenance, review, and gap analysis / impact assessment of external standards, regulatory requirements, and guidance’s associated with biological safety
• Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex’s global laboratory service providers in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives
• Mentor teams, share experience, and provide best practices to biological safety/quality staff related to biological safety systems, corporate policy, and regulatory requirement
• Encourage and foster an environment based upon a foundation of continuous process improvement and industry benchmarking
• Support and lead Arthrex’s business and expansion goals

Education And Experience

• Bachelor’s Degree in Chemistry, Toxicology, Biology, or related science field required
• 2 years relevant experience required
• Previous project management experience preferred
• DABT Certification Preferred

Knowledge And Skill Requirements/Specialized Courses And/or Training

• Specialized training in manufacturing operations, system design and development, terminal sterilization methods, industrial statistics, and technical writing preferred
• Experience in project management tools are highly desirable
• Experience in working with Toxicological Risk Assessments, Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting preferred
• Machine, Tools, And/or Equipment Skills: Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company)
• Solidworks, Minitab, and SAP or corporate ERP systems experience desirable

Reasoning Ability

• Ability to define problems, identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
• Ability to verbally communicate ideas and issues effectively to other team members and management
• Ability to write and record data and information as required by procedures

Language And Communication Skills

• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
• Ability to verbally communicate ideas and issues effectively to other team members and management
• Ability to write and record data and information as required by procedures