- Medical device FDA/ ISO regulatory compliance.
- Design control systems, both hardware and software, for medical devices
- Risk analysis, vendor qualifications and documentation related to medical devices.
- Software and process validations.
- Design and manufacturing engineering in flowmeters.
- Contract Manufacturer Organization (CMO) selection and qualification for medical devices.
- Drawing and document control systems, configuration and management.
- Human factors programs.
- Component acceptance procedures/ non conforming product disposition.
- Audits, gap analysis and response to FDA 483 forms and warning letters.
Independent Consultant, 2008 - Present
- On site in England, assisting a British automated diagnostic system manufacturer to develop a Design Control program and plan for software validation.
- With a large Japanese optical equipment manufacturer, developed a Quality Management System for startup of a medical device division.
Chrysalis Technologies Inc., Richmond, VA , Project Leader, 2002 - 2008
- Developed the Design Control program for this start up medical device manufacturer.
- Wrote 21 SOP's which included ISO and IEC standards.
- Established new product requirements and conducted risk analysis.
- Selected and conducted technical QS audits of 43 contract manufacturing organizations and vendors.
- Conducted validations.
Siemens Process Instrumentation, Hauppauge, New York, Director of Engineering, 2001 - 2002
- Responsible for design and manufacturing engineering for this ultrasonic flowmeter manufacturer.
Controls Corporation of America, Virginia Beach, Virginia, Director of Engineering, 1996 - 2001
- Managed design and manufacturing engineering for this ISO 9001 certified manufacturer of scientific flow control systems.
mdi Consultants, Great Neck, New York, 1995 - 1996
- Associate Consultant in an international medical device consulting firm.
- Conducted software validations, risk analyses and compliance audits.
- Established design control program for a heart laser manufacturer.
National Medical Care, Rockleigh, NJ, Manager Dialysis Equipment Group, 1992 - 1995
- Responsible for design, QA/QC, production and field service of automated kidney dialysis systems.
- Brought a seriously deficient department into compliance during an intensive 2 year FDA investigation.
- Conducted process and software validations systems.
Honors & Publications
- Lloyd's of London ISO 9000 Lead Auditor
Publications and Patents
- Four issued patents; three pending
- MBA Finance, Drexel University, Philadelphia, PA.
- B.S. Mechanical Engineering, Polytechnic University of New York