Edgar W. Hilt

*** ******** **., *********, **. **360 Mobile: 469-***-****, ad1g8i@r.postjobfree.com

Summary

Quality and R&D Professional with over 35 plus years’ experience in multiple areas including; (FDA regulated) medical instrument development, Quality Management, and manufacturing support.

Major strengths include Design Control, Process Control, CAPA, Risk Management and System Integration.

Excellent at developing and documenting electronic products and implementation and training for commercialization.

Success at motivating staff through clear communication and organizational skills.

Professional Experience

B Braun - Allentown PA May 2022 to May 2023

Sr. Design Assurance Quality Engineer Active Device – B Braun, Allentown PA (Remote)

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Performs other related duties and responsibilities, on occasion, as assigned.

Participates in and supports the implementation, development, enhancements, and modifications to software source code, scripts, and procedures; Debugs, troubleshoots, and isolates software problems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development; Identifies parameters, structure, and critical test components.

Oxford - Rocklin, California September 2020 to October 2022

Contractor: Sr. Design Assurance Quality Engineer – DePuy-Mitek Division, Johnson & Johnson – Raynham Mass (Remote)

Assess risk documents for Gaps and complete Gap assessment report for completeness.

Convert and align risk management files with EU MDR updates per, FDA 21 CFR Part 820, ISO 13485

Review design test and inspection method protocols, and test method validation protocols.

Ensure DHF content completion, integrity, and regulatory & standards compliance; for (LVR) labeling verification report.

Aerotek - Richardson, Texas October 2015 to February 2020

Contractor: Sr. Design Assurance Quality Engineer – Abbott Neuromodulation Division – Plano Texas

Lead on-time completion of Design Control Deliverables, Create and ensure on-time execution of Quality Plans for internal development, Clinical Product Development (CPDP), and design change projects.

Convert and align risk management files with the EU MDR updates per, FDA 21 CFR Part 820, ISO 13485

Support design test and inspection method development, and lead test method validation activities, Ensure DHF content completion, integrity, and regulatory & standards compliance; for (LVR) labeling verification report.

Support (NPS) non-product software qualification, including but not limited to writing test protocols for V&V and ensuring validation of all (NPS) qualification.

Supporting RD TMV by reviewing/approval, and authoring TMV’s for System protocol for compliance testing.

Real Staffing, Group - Chicago ILL. February 2015 to September 2015

Contractor: Sr. Quality Engineer - (Phillips Medisize - Plastics) Eau Clare Wisconsin

Root cause analysis, problem solving, continuous improvement and related corrective and preventive action as they relate to complaints, non-conforming material, post-market surveillance (PMS), and other quality data

Develop and manufacture/procure test equipment and inspection systems (tooling, fixtures, gauging, instruments, equipment, software, etc.), including appropriate calibration and preventive maintenance.

Disposition of non-conforming material and Lead for (MRB) Material Review Board

Quality reporting: tracking; compiling; and reporting quality metrics

Review specifications to ensure appropriate designation, specification, dimensioning, and tolerance as they relate to inspection.

Aerotek - Richardson, Texas July 2011 to December 2014

Contractor: Sr. Design Assurance Quality Engineer - (SJM) Neuromodulation Division – Plano Texas

Responsible for working with peers in Research and Development, Process Development, and Clinical Affairs with expert level knowledge in Design Processes and Controls, Risk Management, Experimentation and its associated documentation, and Protocol and Report Creation to ensure products come out of the Development processes well captured in documentation and with demonstrated robust capability and minimal risk. Representing Design Control activities to external reviewers.

Perform risk management and planning activities (Hazard Analysis, Design/Application FMECA, Software FMECA, Fault Tree Analysis) to ensure products and processes are safe and effective.

Review customer complaints, propose corrections or corrective actions, to the product -hardware/software design or usability issues within the defect management system.

Complete Compliance reviews of IEC 14971, IEC 60601-1, IEC 60601-1-11BS EN 60601-1-6, IEC 62304, ISO 14708-1 and 14708-3, BS EN 45502, BS EN 14971, IEC 10993-1 and 3.

Supporting RD TMV by reviewing/approving, and authoring TMVs for System protocol for compliance testing.

Orthofix Inc – Lewisville, Texas April 2003 to March 2011

Quality Engineer - Electrical

Develop testing and inspection strategies to proactively minimize design and process problems and correct problems that occur for new and existing electrical/electronic devices. The position ensures compliance with quality systems and other standards and regulations, company quality requirements, and corporate objectives.

Input and approval for design verification and validation testing of new designs and design changes (including product software/firmware verification) to ensure product design quality and integrity

Input and approval for internal and supplier manufacturing equipment/processes/systems (IQ/OQ/PQ) to ensure process capability and product/process quality; direct responsibility of the same for quality department equipment/processes/systems, including quality department items developed for use by suppliers

Validation of software/firmware used in products and testing systems used to determine product or process conformance. Input and approval for validation of automated processes and software used in the quality system.

Determine appropriate tests, inspections, and validations to ensure components and products meet specification requirements, Supplier qualification, and approval, including related controls stated above

Root cause analysis, problem-solving, continuous improvement, and related corrective and preventive action as they relate to complaints, non-conforming material, post-market surveillance (PMS), and other quality data

Develop and manufacture/procure test equipment and inspection systems (tooling, fixtures, gauging, instruments, equipment, software, etc.), including appropriate calibration and preventive maintenance.

Disposition of non-conforming material.

Input to, and development of, specifications, standards, test protocols, test reports, procedures, and other documentation and records related to the above-listed responsibilities, Quality system compliance in above-listed areas, Quality reporting: tracking; compiling; and reporting quality metrics

Review specifications to ensure appropriate designation, specification, dimensioning, and tolerance as they relate to inspection.

Currency Systems International, INC. - Irving, Texas Apr 2000 to Apr 2003

World Wide Logistics Coordinator Manager

Managed, all areas of distribution including; shipping, receiving, inventory control, and replenishment.

Prioritize inventory level for Depot shipment by performing, the following duties: Review production schedules and related information for Depot orders, to meet site and Depot Inventory level requirements.

Disposition, of returned used or damaged product from the field worldwide for refurbishment. Coordinated quarterly cycle with field service Engineer, and Depot Managers worldwide and reconciliation of lost or missing product to be reported to the Accounting Department Director.

Set up initial spare parts to be shipped with systems. Designed and supported the integration of a parts tracking system, developed Spare Parts inventory (CD).

Member of the ECN team and processor of ECN for logistics worldwide.

Perform Quality inspections of refurbish equipment and write ECN to have them repaired. Write test procedures to test and reship refurbished. Equipment back into service. Arranged overnight emergency shipment of inventory worldwide.

XCI Corporation - Dallas, Texas Jan 1998 to Apr 2000

Product Manager / Manufacture Engineer

Responsible for all aspects of manufacturing and support of equipment produced for integration with energy management systems (HVAC).

Primary responsibilities: Set MRP parameters to ensure appropriate inventory levels, quarterly inventory cycle count, including an end of year count and inventory report to accounting, shipping, inventory control. Oversee parts ordering for turnkey manufacturer, delivery, and fabrication of production HVAC control devices, Qualification of all suppliers. Reliability testing of integrated circuits, and Hardware and software qualification testing. Trade Show coordinator, set up, tear down, and technical advisor during the show.

Customer support including application engineering and warranty resolution.

Also responsible for developing all internal standards and documentation related to these activities

Education

B.S. in Electrical Engineering from University of Texas at Arlington (UTA), August 1988.

Electronics Technician Diploma form DeVry Institute of Technology, February 1995

Summary of Professional Skills

Software

Microsoft Windows, Office 2007 including Word, Excel, Access and Project, Visio Flow charting

Test Equipment Operation

Oscilloscope, Spectrum Analyzer, Flukes Series Scope meters

Electrical Wire Wrap & Manual Wire Wrap Tool

Frequency Counter, Frequency Generator

SMT Solder & De-soldering Stations

Analog & Digital Power Supply

Environmental chambers

Voltage & Current Probes

Certifications

ASQ - Member

CQE, CSSGB

AAMI – Design Control Requirements and Industry Practice

AAMI – Quality System Requirements and Industry Practice

AAMI – General Principles of Software Validation

AAMI – Integrating Risk Management into the Quality System

UL – Medical Equipment and Systems: Designing for Compliance to IEC 60601-1

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