Position:
Founder / Instructor at Medical Device Academy, Consultant at Packard Consulting
Work:
Medical Device Academy
- Orlando, Florida Area since Jan 2013
Founder / Instructor
Packard Consulting
- Chester, VT since Oct 2012
Consultant
Delcath Systems, Inc
- Queensbury, NY Mar 2012 - Oct 2012
Sr. Manager, Regulatory Affairs
Packard Consulting
- Chester, VT Feb 2008 - Mar 2012
External Resource for BSI & Consultant
Albright Technologies, Inc.
- Leominster, MA Jul 2009 - Aug 2011
Director of QA/RA
CAS Medical Systems
Jul 2008 - Sep 2009
Director of Quality
ConforMIS, Inc.
Jan 2007 - Jul 2008
Director of Quality
Z-Medica
Apr 2004 - Dec 2006
Director of QA/RA
Micro-Invasive Technology, Inc.
Apr 2003 - Mar 2004
CEO
Smart Drug Systems, Inc.
2000 - 2004
Consultant
Packard Labs, LLC
2000 - 2003
Owner, Managing Member
Education:
The University of Connecticut 1989 - 1993
BS, Chemical Engineering
AAMI Course in DC
World Class Product Creation 2013 2013 - 2013
Skills:
510(k) Submissions, CE Marking, Canadian Medical Device Licensing, Clinical Evaluation Reports, Lead Auditor, Management Experience (1-100+ People), Strategic Market Plans, Fundraising for Start-ups, Business Plan Writing, Medical Devices, Management, CAPA, Licensing, Supplier Quality, Electronic Submissions, Business Planning, Reports, CE marking, Lean Manufacturing, Risk Management, Auditing, Sterilization, Start-ups, Market Planning, Strategy, Design Control, ISO 13485, FDA, Quality System, PMA, V&V, Regulatory Affairs, Regulatory Submissions, Quality Assurance, Continuous Improvement, Quality Auditing, R&D, 21 CFR, ISO 14971, Pharmaceutical Industry, IVD, ISO, Validation, Product Development, GMP, Manufacturing, Change Control
Interests:
Golf, Cycling, Tennis, Rock Climbing and Running
