321-***-**** acuypn@r.postjobfree.com

I am an engineering team leader with proven experience and ability for driving advances in revenue growth and regulatory compliance, with lean process improvements throughout the organization. I am effective in both teaming or leadership roles where I can energize cross-functional teams through directed successful team facilitation to achieve business targets, objectives and improve supply-chain performance.

1.championing the implementation of lean Six Sigma methods and statistical tools

2.directing successful root-cause analysis and remediation

3.achieving effective failure reporting corrective and preventive actions (CAPA) to eliminate recurring problems (effective root cause analysis)

4.educating colleagues to use effective problem solving techniques and attain compliance

5.Directing the implementation of;

- ISO 9001 Quality Management Standard

- ISO 14001 Environmental Management Standard

- OHSAS 18001 Health and Safety Management System Standard

- AS9100C Aerospace Quality Management Standard

- ISO 13485 Medical Device QMS and FDA GMP regulations (QSR, including preambles)

- ISO 14971 Risk Management and hazard analysis for medical devices

I have certified 26 facilities worldwide to many of these standards for three different Fortune 500 companies. My international experience includes Germany, Japan, the United Kingdom, the Netherlands, Sweden, Mexico and Canada.

Accomplishments/Awards/Certifications

Certified Lean Six Sigma Master Black Belt

Produced over $6 million in revenue growth for my employers during my career

Created lean six sigma training material for course instruction and implementation

Developed a methodology to ensure product and process qualification (PPQ) and product stability

Received the James S. Cogswell Award from the Department of Defense (DIS/DSS) in 1994

Established a balanced scorecard method to measure and control key supply chain assets

Certified Lead Quality System Assessor – Medical, Registrar Accreditation Board (ASQ)

Certified Integrated Management System Manager Quality, Safety and Environmental Systems

Certified Quality Engineer (ASQ)

Certified Reliability Engineer (ASQ)

Expertise

Failure Mode, Effects, & Criticality Analysis (FMECA), risk assessment and remediation

Lean Six Sigma process improvement

Verification and Validation of product designs (IQ, OQ and PQ processes)

Supply chain assessment, control and management

Corrective and Preventive Action (CAPA) generation and implementation

Generating quality system documentation for the fabrication of medical devices

Mechanical, electrical and optical engineering the manufacturing of components for aerospace, automotive, power generation, defense and orthopedic medical products

Professional Experience

Design Quality Engineer

Terumo Cardiovascular Group (Oxford International)

Ann Arbor, MI 2015 - 2016

Terumo (traded as TYO – Nikkei Index) is a global supplier of perfusion equipment, vascular and blood segregation and filtering equipment. The Ann Arbor group is responsible for production and service of the System 1 heart-lung machine used to support the majority of cardiopulmonary bypass surgery in the United States, Japan and the European Union, various blood products and vascular replacement devices. As part of the Design Quality Assurance department, responsibilities included the review and approval of all designs generated by the management group.

Review and approve all testing and design output, including design verification and validation

Coordination of the design engineering change order (ECO) process, including review and approval

Assure compliance with the regulatory requirements of US Code: Title 21 Part 820 and Preamble,

IEC 60601-1 (medical electronic equipment), 93_42_EEC MDD (Medical Device Directive), AAMI HE75 (Human Factors)

Facilitate compliance with the Quality System Regulation (QSR) as enforced by the FDA

Assist with the generation of FMEA tools, including DFMEA, PFMEA and FMECA

Provide and manage product risk management and risk benefit analysis

Manage and review usability engineering and the Risk Management File (RMF)

Perform design control tasks, including design reviews

Complete hazard analysis documents and all QSR requirements pertaining to risk (ISO 14971) and create IQ, OQ, and PQ documentation for new products

Generate the risk management plan and report for executive management

CAPA investigation and remediation

Senior Engineer, Reliability and Compliance

Baxter Healthcare (Oxford International)

Round Lake, IL 2014 - 2015

Baxter Healthcare (a division of Baxter International, Inc. – NYSE: BAX) is a global supplier and manufacturer of pharmaceuticals and medical devices with 2013 revenues of $15.3 billion. Baxter Healthcare is spread across two businesses; BioScience and Medical Products. The BioScience group produces recombinant and blood plasma proteins to treat hemophilia and other bleeding disorders; plasma-based therapies to treat immune deficiencies and other chronic and acute blood-related conditions; products for regenerative medicine; and vaccines. Medical Products produces intravenous solutions and other products used in the delivery of fluids and drugs to patients; inhalation anesthetics; contract manufacturing services; and products to treat end-stage renal disease, or irreversible kidney failure, including solutions and other products for peritoneal dialysis and hemodialysis.

Review factory manufacturing issues, field complaints and accelerated stress test data for failure trends and predictive models for home peritoneal dialysis system reliability for critically ill patients

Analyze component and system failures to determine root cause and appropriate remediation

Perform engineering design of experiments and other lean Six Sigma activities for process improvement

Coordinate regulatory compliance for all federal and foreign government medical device requirements (FDA and EU)

Provide communication and metrics to management for reliability, maintainability and safety status of devices in the field

Quality Engineering Manager

Biomet3i (Goode Consulting)

Palm Beach Gardens, FL 2013 - 2014

Biomet, Inc., a privately held company, is one of the world's leading medical device manufacturers. The company specializes in reconstructive products for hips, knees and shoulders, fixation devices, orthopedic support devices, dental implants, spinal implants and operating room supplies.

Evaluate design risk for medical products life cycles and provided risk mitigation recommendations

Perform root cause analysis for field issues and system failures, FRACAS and CAPA

Support regulatory compliance for all federal and foreign government medical device requirements

Write quality system documentation to support manufacturing operations

Support cell manufacturing efforts, manufacturing engineering tasks and process improvements

Lead Quality Management System Auditor – QA and Reliability Manager

L3 Communications - Linkabit

Melbourne, FL 2012 - 2013

L3 Communications - Linkabit (a division of L3 Communications, Inc. – NYSE: LLL) is a diversified manufacturing company with revenues of $15.7 billion. L3 Communications - Linkabit manufactures radio and electronic equipment for the US Government.

Used prediction tools for several support systems, including the calculation of Mean Time To Failure (MTTF) and Mean Time Between Failures (MTBF) for all SATCOM and RF products

Performed root cause analysis for field issues and system failures, including surface mount boards, cable assemblies and related components

Coordination of CMMI scoring and evalution

Planned and executed a quality systems audit for all L-3 facilities in Florida and California

Ensure quality using IPC J-STD-001D, IPC-A-610, IPC-A-620, IPC-SM-784 and J-STD-032

Provided support for compliance to all federal, state and local requirements related to the product.

Created training materials and provided instruction for internal auditing, problem solving and root cause analysis

Quality Assurance Manager –Reliability Engineer

ITT Mine Defense Systems

Panama City, Florida 2009 - 2012

ITT Mine Defense Systems (a division of ITT Corporation – NYSE: ITT) is a global diversified manufacturing company with 2008 revenues of $11.7 billion. ITT Mine Defense Systems produces various mine countermeasure devices for domestic and international customers.

Supported various programs by using reliability, maintainability and availability prediction planning tools to include the calculation Reliability Maintainability Availability and Safety (RAMS), Mean Time To Failure (MTTF), Mean Time Between Failures (MTBF) and Mean Time To Repair (MTTR), supply chain, data analysis and product safety analysis of electronic and mechanical assemblies

CMMI for the logistic and supply chain

Created training materials and conducts instruction for reliability and safety related topics

Managed the Quality assurance department, supplier quality and customer related interaction.

System safety engineering, including MIL-STD-882, FTA and FMECA

Management of 4 quality technicians

Managing Electrical Engineer, Reliability, Maintainability and Safety (NASA)

EG&G

John F. Kennedy Space Center, Florida 2008 - 2009

EG&G (a division of URS Corp. – NYSE: URS) offers a comprehensive range of professional

planning and design, systems engineering and technical assistance, program and construction management, and operations and maintenance services for transportation, facilities, environmental, water/waste-water, industrial infrastructure and process, homeland security, installations and logistics, and defense systems. With approximately 30,400 employees, URS had sales of over $10 billion in 2008.

Responsible for reliability, maintainability, safety and FRACAS analysis of all high and medium voltage power distribution systems (13.8 KVA+) serving the National Aeronautics and Space

Administration (NASA) facilities at the John F. Kennedy Space Center and Canaveral Air Force Station

Used failure prediction tools for several support systems, including the calculation of Mean Time To Failure (MTTF) and Mean Time Between Failures (MTBF)

Created training materials and provided instruction on reliability and maintainability

Evaluated risk for power distribution systems and provided risk mitigation recommendations to NASA

Performed root cause analysis for accident investigations and system failures

Provided reports to the launch preparation team for medium and high voltage risk mitigation

Senior Reliability and Quality Engineer – Six Sigma Black Belt

Siemens

Orlando, Florida 1999 – 2008

Siemens PG (a division of Siemens AG – NYSE: SI) is a leading supplier of electrical components and systems to companies in the energy and electricity industry. With roughly 40,500 employees, PG has sales of over EUR 12 billion.

Developed a corrective and preventive action (CAPA) protocol within Siemens AG on a cross-functional team including Siemens Medical Solutions in Erlangen, Germany (Division HQ)

Deployed an Integrated Management System (IMS) including DFMEA, PFMEA, FMECA, and FRACAS methods worldwide, developed training materials and trained personnel

Established a product and process qualification (PPQ) procedure for suppliers of crucial components and manufacturing processes

Successfully directed a cross-functional team to identify and resolve repetitive issues and errors that were negatively effecting product quality and customer satisfaction

Provided management and support for root cause analysis and remediation of critical product deficiencies, including human factor analysis

Calculated and tracked the cost performance and critical business indicators, including key supplier metrics, and used this data to manage operations

Director of Compliance - Six Sigma Champion

Micro Med Machining

Miami Lakes, Florida 1997 – 1999

Micro Med (a division of Uniform Tubes) specializes in machining and milling extremely small parts for a wide variety of applications to include class II and III medical devices.

Successfully reduced product defect rates consistently from a high rate of 40,000 parts per million to a low rate of less than 100 parts per million using Six Sigma methods, lean process improvement and the theory of constraints to overcome manufacturing bottlenecks

Established testing procedures to improve risk reduction and product stability

Coordinated and successfully completed the regulatory compliance aspects associated with the introduction of new products

Determined the root cause of defects and employed corrective and preventive actions for mitigation

Managed the regulatory requirements for compliance to all applicable FDA medical product regulations (GMP), and 26 engineers, inspection and test personnel

Regulatory and Quality Engineer – Six Sigma Master Black Belt and Pee Dee Board of Directors

General Electric Company

GE Medical Systems (GE Healthcare)

Florence, South Carolina 1995 – 1997

GE Healthcare provides medical technologies for patient care to include medical imaging and information technologies, medical diagnostics, patient monitoring, life support systems, disease research, drug discovery, and bio-pharmaceutical manufacturing technologies. GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people.

Coordinated the introduction of Six Sigma to General Electric Medical Systems (now GE Healthcare), and accomplished several successful belt projects saving over $2M in production and operating cost

Achieved and maintained facility certification to ISO-9001 quality system standards, ISO-14001 environmental system standards, and all regulatory system requirements (CGMP - ISO 13485)

Managed all compliance activities, including FDA QSR (Title 21 CFR, Part 820), JPAL, and Canadian Medical Device Regulations (CMDR), organized internal audit teams, and established CE, CSA, UL marks for product safety

Supported electronic component production, including surface mount board applications

Participated in the design, verification, validation, testing and distribution of products

Created a centralized system for all manufacturing quality procedures and production history documentation and realized over $2.5 million in revenue growth

President and CEO – Engineering and Consulting Services

Compliance Innovations

Stuart, Florida 1994 - 1995

1.General Electric Company – Reliability and Safety Engineering for electronic medical devices

2.Motorola, Inc. – Quality, Supply Chain Management & Certified Six Sigma Master Black Belt for PCB surface mount applications and products

3.Amitech, Inc. – Quality, Reliability and Manufacturing Engineering support for surface mount component production

4.JTECH Communications, Inc. – Quality and Manufacturing Engineering supporting PCB products

5.Bendix Corporation – Quality Engineering and Regulatory Management

Regulatory Compliance Manager (Reliability, Safety and Manufacturing Engineer)

United Technologies Pratt & Whitney and Optical Systems

West Palm Beach, Florida 1988 – 1994

UTOS (a division of United Technologies Corp. NYSE – UTX) which has sales of $55 billion and employs 222,000, created electromechanical and optical systems for government and civilian applications.

Assured compliance for all product reliability, maintainability, safety, and quality requirements

Received an award (James S. Cogswell) from the Department of Defense for outstanding security compliance in 1994

Established a production operation (manufacturing engineering) for a CO2 laser device, electronic components and worked with a team to find other applications and markets for the electro-optical products

Coached and facilitated continuous improvement teams

Directed 20 personnel

Reliability, Safety, Security and Quality Manager (Manufacturing Engineer)

ICSD Corporation

Kissimmee, Florida 1985 – 1988

ICSD, a privately held company, had sales of approximately $10 million annually and employed 150, manufactured test equipment, precision instruments, simulators and electrical-optical devices for government and commercial applications (no longer in business).

Introduced surface mount technology and wave-solder applications for printed circuit board production, increasing production throughput by over 30%, while reducing labor costs by 75% and enhancing manufacturing quality to a failure rate of less than 200 parts per million

Established manufacturing processes and testing, including a clean room (ISO 6 Class 1,000)

Managed Department of Defense contractual compliance, managed 24 personnel, obtained over $200K in revenue growth from the changes mentioned above

Computer Systems Skills

Software quality and validation - C, C++, Visual Basic, XML programming

Relex/Windchill, MAXIMO, SAP, Lotus Notes, Microsoft Office applications, Microsoft Visio, Microsoft Project, Minitab, Reality Charting (Apollo Root Cause Analysis), Deltek, Costpoint, Tip QA

Education

University of Toledo Toledo, Ohio

Bachelor’s Degree - Manufacturing

University of Michigan Ann Arbor, Michigan

Master’s Degree – Industrial Engineering (ongoing)

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