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Sean joined Experien Group in 2009, possessing over 15 years of experience in the medical device industry. He has particular expertise in the development and implementation of Quality Management Systems that comply with FDA's Quality System Regulation (QSR), ISO 13485:2003, ISO 14971:2007, IEC 60601 electrical equipment series of standards, the European Medical Device Directive (MDD), and other relevant standards. Sean has designed and implemented clean rooms for medical device manufacturers (up to Class 10) and he has been personally responsible for large scale projects in quality assurance and manufacturing process validation, including extensive experience with technology transfers.
At Experien Group, Sean manages all Design Control, Risk Management, and compliance activities for a myriad of client companies’ devices and product lines. He holds a particular expertise in software validation and usability engineering standards (EN 62366:2008) for complex medical devices. Sean supports clients' regulatory submissions (U.S. and international) and he functions as companies' interface with regulatory agencies through audits and inspections. His central responsibilities include:
- Quality Management System development and compliance to relevant standards
- Manufacturing and distribution considerations (e.g., Supplier Quality, Design Control, and Risk Management)
- Interface with FDA Inspectors, Notified Body Auditors and State of California FDB Inspectors
- Internal audits, supplier audits, and management reviews for companies
- U.S. regulatory submissions support (e.g., 510(k)s, IDEs and PMAs)
- Quality requirements and regulatory submissions for CE Marking
PAST COMPANIES AND EXPERIENCE
Sean’s professional career began in 1982 at Dysan Corporation (sold to Xidex Magnetics) in process engineering for the manufacture of computer information storage products. In 1995, he transitioned to the medical device sector, holding management positions at several medical device companies, including Acuson, Siemens Medical Solutions and Boston Scientific. He has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485:2003. He was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. He has also performed as a Sarbanes Oxley (CSA) auditor, ISO 9000:1997 certification coordinator and ISO 13485:2003 auditor.
EDUCATION
Sean received a BS degree in Chemical Engineering from San Jose State University in San Jose, California. |
