Steve P.
About Steve P.
Steve P. is a Senior Manager of Design Assurance at AtriCure, Inc., with a strong background in medical device quality systems and risk management. He has over two decades of experience in various roles within the medical device industry, including positions at Medtronic and Monteris Medical.
Current Role at AtriCure
Steve P. serves as the Sr. Manager of Design Assurance at AtriCure, Inc., a position he has held since 2023. His role is based in Minnetonka, Minnesota, and operates in a hybrid work environment. In this capacity, he oversees the design assurance processes, ensuring compliance with industry standards and regulations. His responsibilities include leading cross-functional teams and managing design verification and validation efforts.
Previous Experience at AtriCure
Prior to his current role, Steve P. worked at AtriCure, Inc. as the Manager of Design Assurance from 2021 to 2023. He also held the position of Sr. Design Assurance Quality Engineer at the same company from 2018 to 2021. During his tenure, he contributed to the development and implementation of quality management systems, focusing on risk management and compliance with medical device standards.
Professional Background in Quality Engineering
Steve P. has a diverse background in quality engineering, having worked at various organizations in the medical device sector. He was a Supplier Quality Engineer/Consultant at Medtronic for one year in 2009-2010 and served as Principal Quality Engineer at Monteris Medical from 2016 to 2018. His experience includes roles as Senior Quality Engineer and Assistant Director of Quality, showcasing a strong trajectory in quality assurance and regulatory compliance.
Educational Qualifications
Steve P. holds a Master of Science degree in Systems Engineering and Regulatory Science from the University of St. Thomas, which he completed from 2011 to 2019. He also earned a Medical Device Manufacturing Certificate from the same university between 2011 and 2013. Earlier, he obtained a BS in Manufacturing Engineering Technology with a minor in Automotive Engineering Technology from Minnesota State University, Mankato, from 1999 to 2001. Additionally, he achieved a Certificate in Medical Device Manufacturing from Hennepin Technical College in 2009.
Expertise in Medical Device Standards
Steve P. possesses extensive expertise in auditing medical device quality systems, with a strong understanding of standards such as IEC 60601, 21 CFR 820, ISO-14971, and ISO 13485. His knowledge extends to design assurance processes, including design verification and validation, process development, and manufacturing. He is skilled in geometric dimensioning and tolerancing, which is essential for ensuring precision in engineering designs.