Over 17 years experience in medical device and pharmaceutical, biotechnology and healthcare industries.
- Engagements with Fortune 1000 companies to provide Quality Systems and detailed regulatory / engineering guidance for Class II and Class III medical device designers and manufacturers. Lead multi-site QSR Audits, Perform Gap Analysis, Implement QSR and Product Remediation Plans, Coordinate cross-functional projects in response to FDA Regulatory Actions: 483’s, Warning Letters, Import Detentions, Consent Decrees.
- Incident Investigation, Root Cause Failure Analysis, FMEA, Maintenance Planning, Equipment Identification, Equipment Criticality and Mechanical Integrity. Perform job-task analysis. Coordinate and develop design requirements, detail equipment specifications, commission manufacturing equipment and processes--P&ID’s, equipment lists, qualification / validation (IQ/OQ/PQ), maintenance procedures, SOP’s--de-commissioning activities and scrap.
- Pulse Oximetry Monitoring Systems Research & Development.
- Managed product test lab as well as directed metrology and calibration efforts
- Testing. Hardware, Software, Environmental Testing, Human Factors, Accelerated Testing, HALT, HASS, ESS, Reliability Demonstration Tests, Production Acceptance Tests, Burn-In, Reliability Growth, Test Protocol Design.
- Process Equipment Maintenance Management: Life Cycle Costing, Mechanical Integrity Ranking, Criticality Ranking, Overall Equipment Effectiveness (OEE), Total Productive Maintenance (TPM), Reliability Centered Maintenance (RCM).
Representative Engagement List
- AED / Clinical Defibrillator Design / Mfg., (Andover, MA, 2010): Product and Management Systems Reliability Assessments and program development.
- LASIK, Intra-Ocular Products Design / Mfg., (USA, Spain, 2009-current): QSR Audits, Site Gap Analysis, Implement Quality System and Product Remediation Plans, Product Remediation Plans.
- Orthopedic Implant Mfg., (Ohio, 2009): FDA Warning Letter QSR Follow up Audit. Executive Management Education.
- Blood Pressure Design / Mfg., (Michigan, Taiwan, China, 2008-2010): FDA Import Detention. Quality System and Device Remediation—Design Controls, Risk Management, Documentation Control, and Training systems.
- IVD Design / Mfg., Glucose/Ketone/Cholesterol Analyzer, (Indianapolis, IN, 2008): FDA Warning Letter. Quality Systems and Device Remediation—Design Controls, Risk Management, Documentation Controls, and Project Management.
- Telemedicine Design / Mfg., (McLean, VA, 2008): BSI Audit Preparation. QSR / ISO Audit. Quality System and Device records preparation for BSI Audit.
- Infusion Pump Design / Mfg., (San Diego, CA, 2007): FDA Consent Decree. Quality System and Device Remediation implementation—Design Controls, Risk Management, Product Root Cause Investigations and product corrections.
- Mobile Fluoroscopy System Design / Mfg., (Salt Lake City, UT, 2007-08): FDA Consent Decree. Quality System and Device Remediation—Design Controls, Risk Management, and Reliability.
- Hemodialysis Design / Mfg., (Modena, Italy, 2006): FDA Import Detention. Quality System and Device Remediation—Design Controls, Risk Management, Product Validation (HW/SW), DHF Remediation, HACCP, Product Root Cause Investigations and product corrections, and Interim Quality Management.
- Tissue Oximeter, (Champaign, IL, 2006): 510(k) Traditional Pre-Market Notification package.
- US Army Vehicle Weapons System, (Sterling Heights, MI, 2004-05): Reliability Technical and Management Liaison between US Government Program Office and System Developer for Stryker MGS and Expeditionary Fighting Vehicle government programs.
- Legal Consultation, (Chicago, IL, 2005): Research Expert Witness for medical device personal injury claim.
- AED / Clinical Defibrillator Design / Mfg., (Chelmsford, MA, 2004-06): Product and Management Systems Reliability Assessments and program development. Program execution for three new product development projects.
- Pharmaceutical / Medical Device Design / Mfg., (N. Chicago, IL, 2003-04): FDA Inspection Readiness. Corporate Metrology/Calibration Laboratory Validation remediation: hardware, software, utilities, facilities, processes, and methods. Develop and execute remediation plans and procedures for Laboratory IQ/OQ/PQ—integrate into existing Quality System.
- Dental Device Design / Mfg., (Franklin Park, IL, 2003): FDA Inspection Readiness. Quality Systems Remediation. Gap Analysis, Root Cause Analysis, Risk Assessments, CAPA Plans, Master Validation Plans, IQ, OQ, and PQ development and execution.
- Urology Stent Design / Mfg., (Racine, WI, 2003): Complaint and Field Failure Remediation. Root Cause Analysis and Process / Yield Improvement for manufacturing processes.
- Medical Device Designer, (Olathe, KS, 2002): Reliability Analysis and Enhancement.Surgical Devices, (McGaw Park, IL, 2002): Reliability Test Methods and Management Training.