Biological Safety Specialist II (R&D)

Requisition ID: 46596  Title: Biological Safety Specialist II  Division: Arthrex, Inc. (US01)  Location: Naples, FL

 

 

 

 

Main Objective:

We are seeking a dynamic individual with biocompatibility experience in the Medical Device industry to join our Biological Safety team in beautiful Naples, FL. We seek a candidate that will continue to improve the team's ability to be an industry leader by developing and maintaining a state-of-the-art biocompatibility program and ensuring compliance of projects in accordance with Quality Systems Requirements. The ideal candidate works well in a collaborative team environment and possesses innate critical thinking skills, along with attention to details, that help solve complex problems and improve processes.

 

Essential Duties and Responsibilities:

• Develop and manage internal programs, with a global perspective, on biological safety risk assessment, 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 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 15% of the time

 

Education & Experience: 3 Years with BS Degree in Engineering, biology/microbiology, chemistry, toxicology or related science field

 

Knowledge:  Frequent use and general knowledge of industry practices, techniques, and standards.  General application of concepts and principles.

 

Reasoning Ability:  Develops solutions to a variety of problems of moderate scope and complexity.  Refers to policies and practices for guidance.

 

Discretion/Latitude:    Works under very general supervision.  Work is reviewed for soundness of judgment and overall adequacy and accuracy. 

 

Skills: 

•           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.

•           Hands on experience managing laboratory testing activities.

•           Test protocol and report writing experience preferred.

• Working knowledge of sterilization processes preferred

 

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