Biological Safety Specialist II (R&D)
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:
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.
• 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.
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.