Manager Medical Device
Resume:
Donald Fox
Email: abqq99@r.postjobfree.com
Address: **** **** ****** ****
City: Phoenix
State: AZ
Zip: 85032
Country: USA
Phone: 714-***-****
Skill Level: Management
Salary Range: $11,000
Willing to Relocate
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Donald M. Fox
2739 East Nisbet Road
Phoenix, AZ 85032
Medical Device Professional
Regulatory Affairs and Quality Systems professional serving the medical device industry. Thoroughly experienced in all of the following;
PMA Applications PMA Supplements
ISO 13485 System Development 510(k) Applications
IDE Applications IDE Progress and Final Reporting
Product Surveillance MDR Reporting
CAPA System Development CAPA System Management
PDP Development Design Correction
Document Control Design Control
Vendor Approval and Auditing Cost Reduction Projects
Metrology System Management Product Safety Evaluation
EMC Evaluation CE Marking and Technical Files
Consulting Engagements
2011 to 2013 - Terumo Corporation, Ann Arbor, MI. - On site activities in resolution of consent decree with the FDA. Performed retrospective complaint review to determine if any MDR reportable events were overlooked and to provide a historical basis for the update of risk assessment strategies and documentation. Provided support for complaint system using a new platform, EtQ. Provided support for nonconformance reporting system also using EtQ.
2008 to 2010 - Cardinal Health / CareFusion, Yorba Linda, CA - Various projects regarding FDA and CE Regulatory Affairs for Class II 510(k) and Class III PMA devices. CE Technical File restructuring for all products to provide uniformity across acquisitions.
2007 to 2008 - General Electric, Salt Lake City, Utah - Complaint system development and implementation during remediation of the Quality System through consent decree with FDA.
Continual smaller engagements with several companies including the SensorMedics Corporation and the Omnica Corporation in Southern California. Also owner/operator of a retail/service franchise in Yorba Linda, California.
Quality Manager - Interface Solutions, Laguna Niguel, CA
2000 to 2005 - Interface Solutions is a privately held company dedicated to the design and manufacture of all forms of equipment used in the catheter industry. Equipment includes balloon forming machines, tubing stretchers, hydraulic and gas pressure testing equipment, balloon folding and wrapping fixtures designed and built to customer specification. Interface Solutions also has contract manufacturing functions for balloons, catheter sub assemblies, and complete catheters. As Quality Manager responsible for;
. Development and implementation of Quality System to satisfy ISO 9000 in 2002.
. Development of customer complaint and product return and repair systems.
. Development of corrective and preventative actions systems.
. Development of all Quality Assurance Inspection activities. Interface Associates capabilities included complete fabrication of machined parts and mold tooling and as such an extensive calibration system was developed.
. Supervision of inspection personnel
. Responsible for all vendor-auditing functions.
. Development of Validation and Verification (V+V) procedures for all equipment. These procedures provided customers with clearly defined Installation, Operational, and Performance Qualification ( IQ, OQ, PQ ) protocols allowing smooth integration into their Quality System.
. Development and implementation of design of experiment protocols and inspection sampling techniques for contract manufacturing functions.
. Development of sampling system in accordance with ANSI Z1.4 and Z1.9 for contract manufacturing functions.
. Creation and maintenance of Technical Files for CE Mark.
Engineering Manager - SensorMedics Critical Care Corporation
1995 to 1999 - SensorMedics Critical Care, formed in 1995 as a wholly owned subsidiary, manufactured the Model 3100A High Frequency Oscillatory Ventilator (HFOV), a Class III PMA device used in the rescue of premature infants. SensorMedics Corporation, the parent company, was privately held and a former division of Beckman Instruments. During this time a clinical trial was concluded and the indication for use was expanded to include larger pediatric patients. Also, after research and development efforts dramatically improved performance, a second clinical trial for further expansion to include adults was started and successfully completed. Responsible for the following:
. PMA Supplement Submissions and Annual Reports for the Model 3100A HFOV
. R&D Engineering of the Model 3100B - Adult HFOV - US Patent 6,085,746
. Performance Validation and Summary of Safety and Effectiveness of the Model 3100B for IDE
. Reliability testing and Failure Modes and Effects Analysis of the Model 3100B for IDE
. Engineering and logistics for FDA approved IDE including multiple clinical site coordination
. Management of all domestic and international service activities
. Management of engineering document control
. Post Market Surveillance through MDR Reporting and Failure Analysis
. Creation of Service Manuals
. Creation and Implementation of Design Controls to satisfy new GMP
Sustaining Engineer - SensorMedics Corp.
1992 to 1995 - SensorMedics, now a division of CareFusion Corporation, is the leading manufacturer of diagnostic and therapeutic respiratory care equipment.
Responsible for sustaining engineering related to all product lines including;
. Pulmonary Diagnostic Systems
. Metabolic Measurement Systems
. Nutritional Assessment Systems
. Sleep Diagnostic Systems
. High Frequency Ventilators
. Pulse Oximetery Devices
Responsible for conception of design changes to affect device safety and effectiveness and improvements in manufacturing and serviceability.
Contributed to approval and implementation of device changes.
Assisted in the development of infrared gas analyzer devices used in the diagnosis of pulmonary function diseases.
Responsible for FDA 510(k) performance testing, documentation, and drafting of approval application for VmaxO System, the first in-vitro diagnostic device using a WindowsO platform.
Responsible for creation of Service Manuals and Training Seminar content.
Responsible for training of European dealership service personnel at European site.
Responsible for creating Manufacturing, In-house Service and Quality Control test procedures.
Responsible for design and implementation of all IQ, OQ, PQ, and other design transfer activities for the VmaxO System, approved by the FDA in early 1995.
Technical Support - SensorMedics Corporation
1988 to 1992 - Provided telephone technical support for all products. Responsible for creating and conducting service training seminars, creation of service manuals, creation and implementation of national and international service systems. Provided interface with OEM device manufacturers.
Manufacturing and QA Reliability Technician - SensorMedics Corporation, Anaheim CA
1986 to 1988 - Performed all forms of quality reliability testing and reporting on all products.
Manufacturing - NeuroDiagnostics Inc., Garden Grove, CA
1985 to 1986 - Performed all forms of manufacturing and quality testing on all products related to neurology including live EMG, NCV, and BAER testing.
Avionics Technician - United States Marine Corps
1981 to 1985 - Performed depot and flight line level repair of Ballistics Computer Systems of the Grumman A6 Intruder attached to VMA Squadron 242 - H&MS 13 - 3rd Marine Air Wing - El Toro, CA
Education
USMC - Advanced Avionics AFTA, NAS Memphis, TN - NAS Oceana, Virginia Beach, VA - Marine
Nuclear, Biologic, Chemical Defense Training
Northeastern University - Boston, MA - 1977 thru 1979
Fordham Preparatory School - Bronx, NY
Patent
US Patent 6,085,746 - Oscillating Ventilator Apparatus and Method (sole listed inventor)
This patent, assigned to the SensorMedics Corporation, now CareFusion, claims improvements to the linear motor used on the Model 3100A HFOV. The improvements led to the successful clinical trial of the Model 3100B which expanded the patient population of oscillatory ventilation to include adults near death due to acute respiratory distress.
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