Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Biocompatibility Specialist for our Global Headquarters in Naples, FL who will contribute to biological safety projects in accordance with Quality Systems Requirements. The ideal candidate will have a Bachelor’s degree in STEM and 5+ years relevant biocomp experience.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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;
• Must be able to travel domestically and internationally up to 10% of the time

Experience and Education:

• BS Degree in chemistry, toxicology, biology, or related science field required
• 5+ years relevant experience
• DABT Certification Preferred

Skills and Knowledge:

• Knowledgeable of FDA and ISO guidelines for the biocompatibility assessment of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of biocompatibility test systems requirements required.
• Hands on experience performing laboratory testing activities.
• Biological safety risk assessment writing experience preferred.
• Working knowledge of device clinical use and associated harms and hazards
• Knowledge of orthopedic surgery principles, theories, and products 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.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

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.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.