Engineer Electrical

LUIS F. ESTRADA, MSEE

* ***** *****

Irvine, CA *2614

Home: 949-***-****

Mobile: 951-***-****

*******@***.***

www.linkedin.com/pub/luis-f-estrada/10/357/546

Luis F Estrada has 35 years experience in engineering. He has worked on R&D, Design and Development, Manufacturing,

Quality Assurance, Validation &Verification, and Supplier Quality Assurance. Also he is experienced in circuit design, R&D,

Quality and fabrication of semiconductor devices including pressure sensors, as well as knowledgeable in Management and setup

of production and Quality at Contract Manufacturer. Luis can design, read and create schematics and mechanical drawings. He

developed products/processes (design, quality improvements, research techniques, etc.) incorporating multiple tasks within the

electronics and manufacturing areas. DFT, DFSS and TQM. Regulatory compliance, and Design Controls. Over twenty years

experience on Medical Device Design, Manufacturing and Quality. Experienced on FDA’s 21CFR Part 820 QSR and Parts 210 &

211 cGMPs and ISO 9001, 14971 and 13485 regulations. Experience also with IPC 600 and IPC 610, IEC-60601, SP10 among

other standards. RoHS requirements in components. EMI/EMC testing and resolving issues. Process, complete, approve and/or

audit Design History File (DHF), Tech File, Design Dossier documentation for Finished Medical Device Products. Worked with

Class II and Class III Medical Devices, also designed and developed medical devices from the inventor’s concept through

production. Subsequently I designed three generations of a device and it has been selling successfully for over 25 years.

Managed multidisciplinary teams of engineers on design and development of electronic projects, along with resolving Quality

issues. I have Audited Companies for compliance with FDA, ISO; verify compliance with the European RoHS Directives and

more. I have managed staff and other engineers when my work required it. Written numerous SOPs, User Operating, Test

Procedures and Technical Manuals. Marketing and sales support for many years. Taken seminars on Project Management and

Technical Writing Skills among others. Used for many years standard software for the PC including Windows, Office, Microsoft

Project, Visio, AutoCAD and more. For more information on my experience please contact me for a personal interview.

WORK EXPERIENCE

Abbott Medical Optics/Engineering Technical Group, Santa Ana, CA

Electrical Engineer IV 7/16/2012 to 11/16/2012

• Assess components' datasheets for functional equivalence and suitability in company application for parts that do not

have exact RoHS equivalent (no like-for-like).

• Redesign circuits to incorporate RoHS-compliant parts that are not exact equivalent to the original parts (no like-for-

like).

a. Work with PCB designer to modify PCB design to accommodate new circuit.

b. Work with PCB designer to incorporate DFM / DFT changes (if any).

c. Work with PCBA supplier to build prototype PCBAs.

d. Bring up prototype RoHS PCBAs.

e. Perform engineering verification of RoHS PCBAs and document results in ER.

• Assess off-the-shelf electronic / electrical sub-assemblies that meet RoHS requirements (motors, motor drivers, power

supplies, computer I/O boards, LCD panels, etc.) for functional equivalence and suitability in company application.

Advanced Sterilization Products/Tata Consulting Services, Irvine, CA

Sr. Electrical Engineer 5/1/2012 to 7/2/2012

• Consulting for ASP a Johnson & Johnson Company: The product is a sterilization unit for medical instrumentation.

• Responsible for supporting equipment & consumable manufacturing located at the Irvine Site.

• Coordinate and lead electrical manufacturing projects as assigned to meet all performance requirements including cost,

quality, safety and environmental criteria.

• Support for all electrical and electronic based manufacturing processes, modifications and upgrades to existing

equipment, design and selection of component modifications, preparation of estimates, generation of capital funding, control

of project budgets, timely execution of installations, equipment commissioning and validation.

• Verify that all electronic components would be RoHS compliant in order to meet the Directives of the European Union.

• Development and periodic review of standard operating procedures and specifications, testing procedures and

specifications, documentation revision control, non-conformance reports, failure investigations, change orders, corrective

action/preventive action documentation, and manufacturing project scheduling and coordination.

• Work in direct support of the Irvine Plant operating units and designated project teams to support manufacturing.

• Provide direct support in routine problem solving of a moderate to complex nature and provide subject matter expertise

in identifying and correcting issues.

St. Jude Medical Neuromodulation/Oxford Global Resources, Plano, TX

Sr. Electrical Test Engineer 8/29/2011 to 12/23/2011

• Consulting for St. Jude Medical Neuro-modulation: The product is a spinal cord neuro-stimulator to relieve severe,

intractable pain of the extremities and the trunk.

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• I performed many different functions in the R&D Department worked on V&V of present and new products and devices.

• Review and validate multilayer PCBs and other hardware devices.

• Performed tooling Validation to help with the resolution of present and past issues that caused a warning letter from

FDA.

Sotera Wireless Inc./Aerotek Engineering, San Diego, CA

Sr. Electrical Engineer 10/4/2010 to 4/01/2011

• Consulting for Sotera Wireless Inc. in San Diego.

• Production of design documentation to present the 510K to FDA for final approval of the product.

• Preparing V&V Documents and write test protocols. Check compliance with standards including ASTM, ISO, EN

AMMI and more including ISO 60601 and all subsets. Conduct tests. Design and conduct DVT tests.

• Design and production of test fixtures. Coordinate test fixture software writing. The fixture function is testing circuits,

systems, and software.

• Verify compliance of all components to the RoHS Directive(s) in order to make the product fit to be sold in Europe.

• Complete the product documentation and Verification. Validation of test processes.

• Resolve any system and hardware problems.

4E COMPANY, Temecula, CA

Director of Engineering (2006-2010)

• Invented and designed automotive electronic device. US Patent granted 11/11/2008.

• In private consultation for SeQual Technologies Inc. 2007, San Diego, manufacturer of oxygen dispensing medical devices.

Wrote the manuals for a new concentrator to be delivered to the military to be used in the war field.

CARDINAL HEALTH (Presently Care Fusion) – PYXIS PRODUCTS, San Diego, CA

Senior Electrical Engineer - (1/2006-12/2006)

• Pyxis a manufacturer of hospital goods dispensing equipment. Sr. EE Member of the Product Focus Team responsible

for ensuring quality and efficiency in our production lines.

• Managed an essential process for the core business, the End of Life. Deal with vendor issues, especially new

replacement for components that reached EOL.

• Verify that all the components including computer accessories be RoHS compliant in order to meet the global market

requirements.

• Check compliance with standards, including ESD/EMC, ASTM, AMMI, 60601 and more.

• Instrumental in leading the division’s focus team, which managed 80% of the company products. Oversaw Electrical

Engineering including the areas of computer consoles and servers that controlled 100% of the products for the company as

well as the Scrub Station line of products.

4E COMPANY, Temecula, CA

Senior Electronic Engineer (2004-2006)

• Spearheaded analog circuit design as part of an industrial controller.

• Designed circuits to perform specific signal conditioning function as part of an interface between sensors and digital side of

the systems.

• Planned and coordinated assembly of PCBs and circuits to be used in Satellite Communications.

MEDTRONIC MINIMED, INC., Northridge, CA

Sr. Supplier Quality Assurance Engineer (1999-2004)

• Manufacturer of the infusion insulin pump for diabetics, along with the continuous glucose meter.

• Oversaw customer service relationships with suppliers, CAPA.

• Supplier Audits verify compliance with FDA, ISO and company regulations including ISO 60601 and ESD/EMC.

• Worked with plastics, injection molding, vendors that molded our cases and other parts.

• Ran tests for compliance with the applicable parts of the ISO 60601

• Represented the Supplier QA in resolving Material Review Board conflicts and disposition of non-conforming material,

CAPA. Member of the Change Control Board for years. Wrote SOPs, MIs and many other documents. I had to do

presentations to train personnel and also outside vendors to make sure they would know our requirements.

• Formed and managed multidisciplinary engineering teams to perform vendor selection processes on key components of the

company products, and to resolve non-conformances of components with vendors.

• Performed some MDR to assist our regulatory department whenever they were short handed. Also as part of the process from

reposting the field returns from device failures.

• I had to use the Design of Experiments system by Medtronic, which I still have. I also had to use statistical analysis like

linear regression and more.

• Identified replacement and verify/validated the compatibility to discontinued EOL components. Verify that all components

comply with the new European Directive about hazardous Materials (RoHS).

• Formed and managed multidisciplinary teams that analyzed and validated circuit designs and components used on company

products.

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• Reviewed and updated the DHF including remediation as needed.

• The MRP program used at Medtronic MiniMed was SAP.

• Protected integrity of the company products through risk analysis, FMEA, and other six sigma tools.

• Started Six Sigma training. Completed Green Belt.

Senior R&D Design Engineer

• Designed circuits and systems as part of new products as well as new test systems and fixtures to test and calibrate new

products. Debugged all problems on the pump and made it the most reliable one to that day.

• Acted as a liaison between R&D and manufacturing, transferring new products into production. Worked in electronic

component engineering verification.

• Worked with manufacturing and quality, leading teams to resolve any conflicts in assembly, calibration and testing of the

product as part of the Continuous Improvement Team.

CHAD THERAPEUTICS, INC., Chatsworth, CA

Senior Project Engineer/Program Manager/System Designer (1993-1999)

• Formed and led the team that designed, developed, and fabricated products and tested equipment from component level to

complete systems. Ran day-to-day manufacturing, quality and engineering operations.

• Designed, validated, started manufacturing, and performed quality sustaining engineering of the Oxymatic for patients on

supplemental oxygen, etc. Designed Circuits, PCBs and all hardware and test fixtures as part of the products.

• Started the Engineering Department at CHAD. Managed vendors and supplier QA. Used SAP as the approved MRP program.

Worked also with our vendors that made our plastic parts including our tubing connectors and resolved all the injection

molding problems that came up.

• Was part of the team that completed the New Quality System at CHAD to obtain ISO 9002 certification. I wrote and

approved SOP, MI and other documents for the system. Worked and updated the DHF as needed.

• Verified compliance of the products with the parts of ISO 60601 that applied to the product and other standards.

• Lead the engineering team to completing design and development of several generations of the Oxymatic using analog,

digital, mixed-signal components and embedded microcontrollers.

• Managed vendors to assure the proper products and materials were delivered to us.

AURA SYSTEMS, INC., El Segundo, CA

Senior Systems Engineer (R&D) (1991-1993)

• Managed Design Projects, led the team that developed and built a pressure transducer to use in automotive application.

• Worked on development of high temperature audio transducer design and development as part of a noise cancellation system

for commercial jet engines.

• Instrumental in the development of semiconductor manufacturing procedures and processes of the AMA (DLP) for HDTV,

and IR projection for commercial, military and aerospace applications.

UDT SENSORS, INC., Hawthorne, CA

Senior Project Engineer/Project Manager/Optics and Electro-optics (1990-1991)

• Managed design, designed and manufacturing of opto-electronic circuits and assemblies from the die level to complete

systems using CMOS and bipolar analog and digital circuits.

• Designed and managed the production team of the Beacon, RF arrow retrieval system.

• Designed X-Ray scanners for security and medical applications. Designed and built a 256-channel X-Ray scanner to be the

precursor of the ones used in security at airports nationwide today.

AMETEK MICROELECTRONIC DIVISION, El Segundo, CA

Production Manager (1989–1990)

• Managed Silicon Wafer Fabrication Department of 25 employees. Ran processes as well as quality.

• Managed a team that completed two years production of pressure transducers with half of the normal work force in nine

months.

Senior Project R&D Engineer (1987–1989)

• Managed and performed development, R&D, and manufacturing processes of Silicon Pressure sensors and transducers from

raw silicon to terminated transducers.

BDL ELECTRONICS CO. /LITE PEN COMPANY, Los Angeles, CA

Engineering Manager / Sales Technical Support (1985-1987)

• Ran quality assurance and product inspection.

• Designed and managed manufacturing of electronic modules to be used in the aerospace industry.

• Designed circuits and systems using Digital, Analog High Speed and mixed signals integrated circuits.

• Managed design and fabrication of the ETCU to trim the Boeing 747 engines.

• Managed design, development and manufacturing of a light pen for the IBM PC.

CALIFORNIA G & K DESIGN INC., Torrance, CA

Principal Electronic Design Engineer (1981-1985)

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• Responsible for system design, development, fabrication, quality, installation and customer service and training for the

company’s products including audio, audiovisual, commercial, industrial and medical, from component level to systems.

• Designed, built and installed sound, lighting and controls for animated and Theme Park Shows.

• Worked with the inventor, designed and built the first Oxymatic, electronic Oxygen conserver.

BANCO de Bogotá - Bogotá, Colombia, South América

Sr. Systems Analyst (1979 -1981)

• Managed and performed design, development and installation of Banking Computer Applications.

HOSPITALICA, LTDA - Bogotá, Colombia, South América

Service and Maintenance Manager (1978-1979)

• Managed and performed Field Service Management of Medical Electronic Equipment in hospitals nationwide. Generated

contracts with hospitals to service, maintain, and repair all medical and surgical equipment.

ACADEMIC PREPARATION

Pontificia Universidad Javeriana, Bogotá, Colombia

• B.S.E.E., M.S.E.E., Electronic Engineering (1978)

Extensive Computer Knowledge:

• Proficient in PC including Windows, Office, Microsoft Project, Visio, AutoCAD and more.

• Fluent in both English and Spanish. US Citizen.

PROFESSIONAL DEVELOPMENT ACTIVITIES

• Certificate of Management & Leadership - CSUN, Northridge, CA (1998)

• Six Sigma, Green Belt - Theoretical Portion - SMTEK International (2004)

PAPERS WRITTEN

• “FIBER OPTICS IN COMMUNICATIONS SYSTEMS”. Thesis to obtain Electronic Engineering Degree (1978)

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