Richard Skowyra Ii
About Richard Skowyra Ii
Richard Skowyra II is a Quality Control Engineer IV at Organogenesis Inc, where he has worked since 2009. He has extensive experience in medical device engineering, product development, and regulatory compliance, having previously held roles at Organogenesis Inc and Rensselaer Polytechnic Institute.
Current Role as Quality Control Engineer IV
Richard Skowyra II has been serving as a Quality Control Engineer IV at Organogenesis Inc since 2009. In this role, he focuses on ensuring the quality and compliance of medical devices and biological products. His responsibilities include executing sterilization validations on final products and packaging, as well as conducting rigorous shipping validations according to International Safe Transit Association guidelines. Skowyra's work is essential in maintaining product integrity and meeting industry standards.
Experience at Organogenesis Inc
Richard Skowyra II has extensive experience at Organogenesis Inc, where he has held multiple roles since 2004. He initially worked as a Product Development Associate from 2004 to 2005, followed by a position as a Medical Device Engineer from 2005 to 2009. His contributions include leading shelf-life stability studies for raw materials and final products, and performing capability analysis and engineering studies to enhance process efficiency. Skowyra has been instrumental in the development of a novel culture insert, which resulted in a successful FDA submission.
Academic Background in Biomedical Engineering
Richard Skowyra II studied Biomedical Engineering at Rensselaer Polytechnic Institute, where he earned both a Bachelor of Science and a Master of Science degree from 1997 to 2003. His academic training provided a strong foundation in engineering principles, which he applied throughout his career in the medical device and biological product sectors.
Previous Role as Graduate Teaching Assistant
Before his tenure at Organogenesis Inc, Richard Skowyra II worked as a Graduate Teaching Assistant at Rensselaer Polytechnic Institute from 2001 to 2003. In this role, he supported faculty in delivering course material and assisted students in understanding complex engineering concepts. This experience contributed to his development as an educator and mentor in the field of biomedical engineering.
Regulatory Compliance Contributions
Throughout his career, Richard Skowyra II has participated as a key member of cross-functional teams during multiple FDA inspections. His involvement has been critical in ensuring that Organogenesis Inc meets regulatory compliance requirements. Additionally, he has conducted process validations on novel combination biological products and medical devices, showcasing his expertise in maintaining high standards in product development and quality assurance.