Lakewood, California, United States
I am an Electrical Engineer with experience in medical device and engineering management regarding designs and redesigns for EMC and EMI compliance, including: testing, designing, implementing, fabricating, and manufacturing of medical devices for diagnostic and therapeutic systems for patients or research projects. Improved and engineered product development in accordance with GMP, ISO, V&V and FDA requirements.
I am a candidate for employment who is currently taking job readiness workshops that are enhancing my employability skills and strengths to re-enter the engineering field. Examples of workshops completed include: STEPS (Steps to Economic and Personal Success), Building Computer Skills For Job Search Levels 1, 2, & 3, and Microsoft Office (Word, Excel 1 & 2, PowerPoint, & QuickBooks). Supported clients with service and technical support for all Medical Devices.
Manage problems and solutions for Medical Devices Verification/Validation of Test Protocols Component failure investigation and analysis Project Management Design and Developement Plans
* Evaluated manufacturing burn-in problems for sterilization products while documenting on troubleshooting forms and nonconformance reports. *Component failure investigation and anaylsis * Assessed and succeeded to resolve prolonged problems with NX Systems and reoccurring power interruption. CAPA used to correct this problem. * Provided management with problem documentation summaries, solutions and methods to prevent their recurrence. * Generated hundreds of Technical Evaluations within NCR reports for nonconforming component failures. Worked on Change Orders and the CAPA process. * Repaired test equipment for subassembly testing and electrical safety testing; assisted in generation of IQ, OQ & PQ validation test protocals and implementing test methods. * Setup new electrical test equipment and procedure for receiving inspection. * Created rework instructions for manufacturing repairs and CO change orders when necessary. * Identified new vendor related problems and returned original packaging to the manufacturing floor locations to reduce failures. * Implemented materials, monitors and new methods to improve and establish ESD Testing for work stations and technicians accessories and reduce PCB failures.
~ Improved and engineered product development for CHLA, SensorMedics and Cardiomedics medical devices in accordance with GMP, ISO, V&V and FDA requirements. ~ Consulted with CHLA, UCLA, Amylin doctors, QC and QA staff to ensure safe and compliant patient or research animal testing/operations. ~ Operational, design, and medical application knowledge of the following Cardiopulmonary Medical Devices: * Counter Pulsation Therapy * Pulmonary function-diagnostic testing systems * Ventilators * Oxygen saturation * Respiratory gas mass spectrometers * Stress- test and exercise equipment * Sleep laboratory systems * Pacemakers * Physiological catheters ~ Prototype design was conducted for multiple projects leading to solutions and improvements. ~ Managed multiple levels of employees: Fellow Doctors, nurses, technicians and engineers. ~ Utilized communication skills and full documentation to achieve company goals, engineering changes, FDA required documentation, improved product sales, service and training. ~ Strong knowledge of engineering process development and analytical problem-solving for designing, implementing, fabricating, manufacturing of medical devices for diagnostic and therapeutic systems for patients or research projects. ~ Reviewed problems concerning patient operation and comfort. ~ Provided improved product solutions and implemented corrections. ~ Consulted with higher management regarding amended manufacturing methods and budget adjustments. ~ Provided nationwide implementation and service for 10 Airspec Mass Spectrometers capable of measuring respiratory physiology for metabolism, diagnosis of infant (SIDS) and adult sleep disorders. ~ Analog to digital, PC driven controls and patient data storage with hard copy. ~ Evaluated, purchased, trained, serviced and adapted all systems under my control.