SUMMARY:

• PhD electrical engineer with over 35 years of hands on industry experience
• Over 25 years of medical device experience on the R&D and product development as well as on the Regulatory Compliance and Quality System
• Proficient with the US Confidential regulatory compliance requirements and submissions .
• Proficient with Global regulatory compliance requirements including EU MDD, EU MDR, Canada, Brazil, China and RoW
• Proficient with ISO 13485 (Medical Device Quality Management System), ISO 14971 (Medical Device Risk Management), UL2900 Cyber Security Standards, 21CFR820.XX ( Confidential Code of Federal Regulations), and IEC60601 - 1 2 nd and 3 rd editions.
• Proficient with the new EU Medical Device Regulation requirements.
• Experienced in team building; have put together many teams of engineers, medical officers, university faculty and support staff for various projects with the military, civilian, car industry, Government and educational applications.
• Highly experienced in Quality Systems (IQ, OQ, PQ), Design Controls, Design History File, Device master Record, Medical Device Reprocessing, Sterilization, Labeling, Risk Management, Failure Analysis and Root-cause Investigation, Medical Device Remediation, Clinical Evaluation Reports (CER), Corrective Actions and Preventive Action (CAPA), Non-Conformance (NC), Project Performance Evaluation, responding to Confidential 483 warning letters, Design, hardware and software Verification and Validation, Clinical Studies, FMEA (DFMEA, PFMEA, AFMEA), GMP, and all other medical device related areas.
• Senior-level experience in the medical device design, development and manufacturing, including drug delivery systems, infusion pumps, IVDs, biomarkers, insulin pumps, lung pressure monitors, fetal monitors, ultrasound scanners, hearing aid devices, patient monitoring systems, pulse oximeters, defibrillators, AEDs, vein locators, ventilators, etc.
• Senior-level experience in the development of test protocols, design verification and validation
• Have been teaching and training Risk Management and Design Controls for over 15 years
• Strong communications and presentation skills.
• Have been teaching and training effective communications and presentation skills for over 10 years.
• Strong customer service experience.
• Have been teaching (University Graduate level courses) and training high quality and effective customer service techniques for over 20 years.
• Strong hands-on experience in a wide range of electrical, mechanical, and biomedical engineering areas including electromechanical design, product development, manufacturing, product testing, analog and digital design, RF, embedded systems, digital signal processing, ultrasonic and applied acoustics, SONAR, electromagnetic fields, antennas, audio, video, wireless, telecommunication, networking, PLD, CPLD design and development, optical systems, schematic entry and PCB layout using OrCAD, Cadence Allegro, Altium, etc.
• Over 25 years of program and project management experience, having successfully directed and managed multiple projects in the Government, Civilian, and Medical industries
• Over 25 years of teaching experience as a university professor at graduate and undergraduate levels, on ground and online, plus serving as a program dean for one of the largest educational institution in US
• Highly experienced with many application software packages including Microsoft Office products such as Word, Excel, Power Point, Project, Visio, and other popular application software such as Adobe Photoshop, Dreamweaver, Corel Draw, and many others.
• Strong presentation skills. Have presented technical and non-technical materials for over 30 years as a part of teaching, training, management, and research to audiences that included government and local officials, students, executive managers, various Board of Directors, and department heads.

WORK EXPERIENCE:

Confidential, Monroeville, PA

Senior Regulatory Manager

Responsibilities:

• Production and submission of Confidential 510(k)s for newly designed and developed Confidential Respironics ventilators
• Production and submission of regulatory documents for Health Canada for three Confidential respiratory medical devices
• Respond to Confidential questions and concerns for the previously submitted 510(k)s
• Project Lead - Transformation of EU MDD documents for the compliance with the new EU MDR
• Production of CEPs and CERs
• Production of EU Technical Files
• Support and coordinate International device registration for Confidential Respironics ventilators

Confidential, Raynham, MA

Senior Regulatory Manager

Responsibilities:

• Provide regulatory support for the development and lunch of a newly developed Sports Medicine Visualization Product
• Project Lead - Production of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)
• EU MDR Project Manager - Transformation of the EU’s MDD 93/42/EEC documents for compliance with the new EU MDR to include technical files, labeling (IFU, device and shipping box labeling), biocompatibility, clinical and non-clinical data, standards, etc.
• Production and submission of regulatory documents for Health Canada for a newly developed DePuy Mitek Visualization System
• Represent Regulatory Affairs in all NPD (New Product Development) and Legacy Product meetings
• Serve as the Subject Matter Expert (SME) in Technical (HW and SW), Laser, Video, and Optical Systems related meetings
• Manage, coordinate, and support International registration of medical devices (EU, Canada, Brazil, China, ROW)
• Production of Visualization Systems 510(k)s for Confidential to include biocompatibility, labeling (IFUs, device ad shipping box labeling), UDI, standards, clinical and non-clinical data, etc.
• Review and approval/rejection of engineering change orders
• Review and approval/rejection of FMEAs (DFMEA, UFMEA, PFMEA)
• Review and production of Confidential, EU, and ROW regulatory documents
• Production of 510(k)s for Confidential
• Production of Technical Files and other required documents for obtaining European CE marking
• Production of DoCs (Declaration of Conformity)
• Communication with the Confidential and responding to their letters
• Communication with the manufacturers and supplier to ensure compliance with US and Global regulatory requirements

Confidential, Milwaukee, WI

Senior Regulatory Manager

Responsibilities:

• Regulatory Project Manager - Confidential ’s Patient Monitoring Systems
• Successfully built a team of regulatory compliance specialists to produce documents necessary for the submission three Confidential Traditional 510(k)s for Confidential medical devices
• Provided Regulatory and Technical SME support for Confidential legacy and new products
• Mentored and trained regulatory affairs managers, engineers, and specialists

Confidential, Mansfield, MA

Senior Manager

Responsibilities:

• Manage Regulatory Compliance and Quality System activities for Confidential reusable products
• Creation and submission of 510(k)s, and NDAs, and supporting regulatory documents for Confidential reusable products including labeling, biocompatibility, standards, clinical and non-clinical data, IFUs, etc.
• EU MDR Project Lead - Lead a team of RA engineers to develop EU MDR compliant documents for a newly developed Visualization System to include labeling, biocompatibility, standards, clinical and non-clinical data, IFUs, etc.
• Review and update internal Covidien Regulatory Compliance and Quality System documents and procedures
• Creation and submission of Covidien Regulatory Compliance documents and procedures for Health Canada
• Provide regulatory compliance support for Confidential /Covidien reprocessed products
• Provide SME support for Confidential process compliance with ISO 13485
• Provide regulatory compliance SME support for the wireless upgrade to Covidien patient control monitoring systems

Confidential, Andover, MA

Senior Regulatory Affairs Project Manager

Responsibilities:

• Provide Regulatory Compliance support for Confidential ECR medical products
• Review, evaluation, and approval of US and Global medical device documents including PMA and 510(k), European CE, Canadian CSA, Chinese CFDA, etc. for the purpose of Regulatory Compliance with medical device requirements and standards
• Regulatory Project Manager - Confidential Patient Monitoring Systems (vital signs, EKGs, ECGs, BPM, Pulse Oximiters, etc.)
• Product labeling manager to ensure device, shipping box, IFUs, and other labeling related compliance labeling requirements for US and rest of the World
• Lead the study and creation of plans, protocols and procedures to bring Confidential products in compliance with the upcoming EU MDR
• Creation of Clinical Evaluation Reports (CER)
• Production and submission of regulatory documents for Health Canada for Confidential medical devices
• Provide Regulatory Assessments (RA) for engineering change orders (EC)
• Review, evaluation and approval of engineering change orders (EC)
• Provided SME (Subject Matter Expert) support to engineering, complaint handling unit (CHU), and HHE (Heath Hazard Evaluation) teams
• Provide SME support to the device manufacturing team for the failure analysis and root cause investigations
• Peer review and approval of technical documents including device specifications, engineering design, manufacturing, verification and validation, test reports, and test protocols
• Provide SME support for the submission of a Class III PMA
• Provide SME support for the compliance with the IEC 60601-1 3rd Edition
• Provide SME support for the PMA submission risk management
• Provide SME support for compliance with US and International Standards

Confidential, West Chester, PA

Senior RA / QA Project Lead

Responsibilities:

• Provide US and Global Regulatory Support for Confidential Orthopedic products
• Development of Risk Management strategy and documents
• Develop Risk Management Remediation Plan
• Lead the production and submission of Regulatory documents for Health Canada Class III and Class IV devices (Orthopedic products).
• Design History File Remediation to update biocompatibility, standards, labeling (IFUs and device related labeling), risk management, clinical and non-clinical data, post market adverse event reporting, etc.
• Develop Design Controls plans and documents
• Develop ISO 14971 Compliant Risk Analysis including the review and analysis of legacy documents and complaints, calculating the probability of occurrence, studying DHF for Objective Evidence and Gap to support Risk Analysis
• Participation in Analysis of Clinical Studies to identify known and new clinical risks
• Production of Clinical Evaluation Plans and Reports
• Production of Complaint Risk Analysis to pass Confidential compliance audit through identification of hazard, hazardous situations, and potential causes of harms, etc.
• Production and analysis of risk management documents (DFMEA, PFMEA, risk reports, complaint analysis, creation and modification of Design & Clinical Risk Management documents, etc.) for orthopedic tools, devices, and products manufactured by Confidential
• Evaluation and correction of Verification and Validation documents

Confidential, Cincinnati, OH

Senior RA / QA Project Manager

Responsibilities:

• Provide regulatory support for the submission of Confidential ’s newly approved Computer-Assisted Personalized Sedation System (Sedasys) Class III PMA medical device.
• Facilitating and guiding the migration of the Sedasys System’s compliance to the IEC 60601-1 standard from the 2nd edition to 3rd edition.
• Providing quality engineering and compliance support for manufacturing of the Sedasys System
• Provide Design Control leadership
• Review and approval of sterilization and reprocessing submission to the Confidential
• Review and approval of document changes at both Confidential and Confidential ’s contract manufacturing companies
• Review and approval of non-conformance documents at Confidential ’s contract manufacturing companies
• Creating Corrective And Preventive Action (CAPA), Non-conformance (NC), presentations related to products manufactured at Confidential ’s contract manufacturing companies
• Perform CAPA and Non-conformance study on the Sedasys System to resolve the non-conformance issues
• Participating in hazard and risk analysis, risk evaluation, and risk management processes at Confidential
• Review and approval of the Confidential ’s process compliance with the ISO 1497, Confidential 21CFR820.100 and the IEC 60601-1 2nd and 3rd edition

Confidential, Richardson, Texas

Senior QA Project Manager

Responsibilities:

• Provide regulatory support for the submission of a new medical device to the Confidential
• Create verification and validation protocols for a state-of-the art digital laser scanner used in the creation of highly accurate dental impressions and fabrication of highly quality dental crowns.
• Review of the D4D’s Class II Dental Laser Scanner’s 510(k) submission to the Confidential to ensure its compliance with the IEC 60601-1, ISO 14971, and Confidential 21CFR820.100 standards
• Provide Design Control support for the newly developed Dental Laser Scanner
• Review the design and manufacturing of the newly developed Dental Laser Scanner
• Performed CAPA and Non-conformance investigation on the Laser Scanner and resolved multiple non-conforming issues

Confidential, Silver Spring, Maryland

Senior Project Manager

Responsibilities:

• Technical Project Manager on a high-profile national project involving the Confidential, the DoD, the Confidential, and the medical device industry on testing, verification, validation and performance evaluation of the ventilators used in the Confidential ’s Strategic National Stockpile (SNS)
• Built and managed a large team of hardware, software, and systems engineer to conduct the above project.
• Held daily, weekly, and monthly meeting to evaluate the project progress level
• Held frequent communications with the project stakeholders to properly support the project.
• Developed test protocols for testing, verification, and validation of transport ventilators
• Developed medical device design verification and validation training and educational 3documents
• Collaborated with several Washington D.C. area hospitals on the production and analysis of the MDR and MAUDE data
• Produced the final technical report for the project
• Performed CAPA and NC study for the transport ventilators used in the Confidential ’s SNS stockpile

Confidential, Silver Spring, Maryland

Senior Electronic /Quality/Systems Engineer

Responsibilities:

• Medical Electronic Lab Leader - Division of Electrical and Software Engineering
• Hired and mentored engineers and support staff
• Built several teams of hardware, software, and system engineers for multiple projects
• Developed road maps for various projects
• Developed and presented multiple effective communications and presentation skills classes
• Lead, managed, and successfully completed multiple medical device related projects
• Reviewed hundreds of 510(k) and PMA submissions for a variety of medical devices including AEDs, Defibrillators, Patient Monitoring Systems, Infusion Pumps, Fetal Monitors, Ablation Systems, Ventilators, Proton Therapy Systems, Hearing Aid Devices, MRI Systems, CT Systems, Laser Surgery Systems, Dialysis Systems, Lung Pressure Monitors, Glucose Level Meters, Pulse Oximeters, Vein Locators, etc.
• Reviewed a variety of submissions on medical device sterilization and reprocessing
• Performed fundamental and applied research pertaining to medical devices and systems including drug delivery systems, external and implantable defibrillators, AEDs, fetal monitors, infusion pumps, ventilators, etc.
• Designed, developed and implemented educational curricula and courses to train Confidential personnel.
• Designed and developed electronic instrumentation to support the research and at Confidential using the latest state of the art electronics instruments such as spectrum analyzers, oscilloscopes, signal and impedance analyzers, frequency counters, infrared and thermal cameras and measurement devices, light meters, etc. and the latest software tools such as MATLAB, CAD/CAM programs such as AutoCAD and SolidWorks, CADENCE Allegro and Altium PCB analysis, schematic capture, and layout, etc.
• Provided SME support on a variety of matters involving education, training and employee development programs
• Participated in medical device sterilization and reprocessing workshops and trainings
• Reviewed research protocols for the evaluation of medical devices and recommended new and alternate methods for testing and data analysis
• Produced a variety of reports and summaries on the safety and effectiveness of medical devices
• Analyzed and reviewed post-market adverse event reports concerning medical devices and radiologic products
• Maintained liaison with other governmental agencies, regulated industry, researchers, and other key stakeholders to provide guidance on policies, negotiate for the acceptance of new or revised policies, and work towards common goals
• Participated in several task forces and study groups related to resolving issues in the medical device community
• Participated in many Confidential 's CAPA and NC study group meetings and workshops
• Member of several Confidential medical device working groups (Infusion Pumps, Defibrillators, Batteries, Ventilators, Fetal Monitors, Orthopedic Medical Devices, etc.)

Confidential, Arlington, Virginia

Dean of Technology Programs

Responsibilities:

• Directed and managed several technology programs including Electronic Engineering Technology (EET), Computer Engineering Technology (CET), Electronic and Computer Technology (ECT), Biomedical Engineering Technology (BMED), and Telecommunication & Networking (NCM/NSA)
• Lead the development of course contents and curriculums for all Engineering programs
• Hired and trained chairpersons, faculty members, and support staff
• Defined standards and developed cutting-edge technology hardware/software systems for educational purposes used at over eighty DeVry campuses and centers throughout United States
• Provided leadership and made strategic decisions for the Information Technology programs
• Principle adviser to the IT Department in the selection and purchase of new IT equipment
• Chaired the National Projects Committee for all DeVry campuses and centers across the United States
• Lead efforts of the National Course Development Committee to establish graduate level Electronic Engineering program at Confidential
• Provided support and guidance to the VP of Academic Affairs and the Department of Student Services to lead strategic planning to enhance the quality of education at Confidential
• Directed and lead the efforts to obtain the first awarded accreditation (by ABET) of Technology Programs at the Arlington Campus of Confidential
• Designed and developed many electronic and electromechanical projects, implementing analog, digital, embedded microprocessor, microcontroller, digital signal processing, and other technologies and using the latest software tools such as MATLAB, AutoCAD, SolidWorks, Cadence OrCAD and Allegro, Altium, and other PCB analysis, schematic capture, and layout.
• Managed student retention, recruitment, and graduation efforts for the Technology Department, leading to a consistent increase in all three areas
• Developed conflict resolution and communications between students, parents, and faculty

Confidential, Mobile, Alabama

Senior Program Manager

Responsibilities:

• Built a team of engineers and university professors to design and develop an Energy-Efficient Smart Home powered by fuel cells, and other natural energy sources such as solar, and wind. The Smart Home was a sophisticated system using multiple microprocessors along with various sensors, and smart computer algorithms to optimize the use of energy. It was a four-year, eight-million dollar project funded by the Department of Energy.
• Designed, developed, and manufactured all electronic hardware and software systems for the entire Smart Home project mentioned above from start to finish
• Built a team of engineers and the support staff to designed and develop triage systems (robot and cane) with medical application for the search and rescue by employing the latest sensor and embedded systems technologies
• Designed and developed precision high-accuracy 3-D machine controller system with sub-millimeter resolution
• Developed and implemented verification and validation protocols
• Designed and developed switching power supply for use in mobile military radars
• Designed and developed high-resolution and high-accuracy ultrasonic measurement system
• Designed and developed electronic lumber moisture measurement systems for the local industry
• Used the latest electronic instruments such as oscilloscopes, signal and spectrum analyzers, signal generators, frequency counters, time-domain refelctomers, infrared and thermal camera systems, precision frequency generators, etc. and the latest software tools such MATLAB, CAD/CAM programs such as AutoCAD, Mechanical Desktop, SolidWorks, CADENCE OrCAD PCB analysis, schematic capture, and layout, etc.
• Mentored and trained hardware and software engineers and technicians
• Created and submitted numerous proposals with government and military applications
• Developed web-based applications including multimedia applications
• Designed and managed databases to support the web applications
• Developed and built-up cross-functional electronic design team with focus on home-automation systems