As a Research Scientist and Mechanical Engineer, I actively design test plans, test procedures, test articles, determine and plan resources requirements, including test personnel and equipment, and efficiently lead teams during test execution. Successfully mentor and train junior staff to achieve organization’s goals and objectives. Generate formal reports regarding test budgets, brief stakeholders on progress, evaluating and document results. Participate in technical planning meetings, providing project status versus budget to project management staff. Research and develop additional technical information training in areas related to security equipment testing, including non-intrusive inspection, and associated scientific disciplines, physical security applications, human factors, operations research, statistics, electrical/mechanical engineering, and systems engineering.

As a Manufacturing Engineer, I coordinated equipment and process changes as well as evaluated and approved engineering changes, and successfully developed detailed work standards for assembly and operations resulting in scrap reduction from 5-20% to 1%. I assumed responsibilities for developing routing processes for ERP, implementing systems and improvement strategies for material flow, providing cost estimates to assist with Make/Buy decisions. Performed DOE and helped develop IQ, OQ, and PQ procedures for execution of validations. Trained employees on SOPs for various departments, including Purchasing, Inspection, Calibration, Clean Room Activities, Service/Repair, Complaint Handling, Auditing, Good Documentation Practices, etc., and assisted Management Representative during audits to obtain ISO 13485 certification. Worked closely with suppliers to coordinate field failure investigation, and reported and tracked suppliers’ complaints and performance. Coordinated external testing for Sterilization, Shipping, Packaging, Cleaning Validations. Worked closely with suppliers to coordinate field failure investigation, and reported and tracked suppliers’ complaints and performance. Effectively developed environmental monitoring procedures to ensure product sterility and quality as per FDA and ISO standards. Assisted with planning and purchasing of quality software for calibration, complaint handling, statistical analysis, etc.

Minimized any negative impact through evaluation of component manufacturing process improvements and its influence to plant assembly operations. Worked closely with Planning, Operations, and Finance departments to carry out capacity analysis, including development and innovative solutions provision. Assisted with line balancing and cycle time analysis to provide current production metrics. Outlined documents for process qualifications in regards to IQ, OQ, and PQ and provides information for Process FMEAs to develop robust manufacturing processes. Developed and revised documentation for new and existing products, including BOMs, SOPs, routers, etc. Designed manufacturing-related fixtures using SolidWorks and establishing preventative maintenance and calibration plans. Experienced in establishing manufacturing parameters, using DOE and statistical analysis through MiniTab and Quality Companion software. Documented and maintained all work as per Quality Systems requirements, including FDA CFR 820 and ISO 13485 through Oracle. Trained staff in regards to changes in the manufacturing processes. Participated in CAPA and NCR investigations to determine the appropriate actions needed to effectively eliminate the non-conformance for implantable device as well as in audit line processes to meet Quality Systems requirements, including FDA CFR 820 and ISO 13485. Performed Root Cause Analysis on scrap to maximize efficiency and profit. Developed scrap codes to effectively identify fixtures and processes, which robust. Pareto scrap issues, initiate ECO to reduce scrap and streamline manufacturing processes. Actively reviewed components issue as part of the Material Review Board. Initiated ECO (Engineering Change Order) for components, products, First Article Inspection, and Pilot Work Orders. Experienced in GLP and GMP and clean room practices.

Assisted in manufacturing processes development, verification, and validation for new and existing products, utilizing Lean, Six Sigma, 5S, Value Stream Mapping, etc. Successfully collaborated with various departments to develop capacity planning and assembly changes, and assisted in line balancing for Atriclip products. Helped in Kaizen events organization, resulting in scrap reduction by 20% for class III cardiac implantable medical device. Provided stakeholders with the data regarding capacity, quality, and productivity metrics as well as informed designers and engineers about manufacturing-related fixtures. Generated documents for process qualifications as per IQ, OQ, and PQ and provided information for Process FMEAs to develop robust manufacturing processes. Experienced in GD&T and the relations to welding, milling, stamping, turning, casting and grinding, and general assembly processes. Assumed responsibilities for error proofing in the manufacturing process, conducted time studies and established manufacturing routers, while considering cost and quality initiatives. Documented and maintained all work in compliance with Quality Systems requirements, including FDA CFR 820, QS 9000, and ISO 13485 through Master Control and ProCal. Captured In-Process nonconformance parts and issuing NCRs for AtriClip. Participated in CAPA and NCR investigations to determine the appropriate actions needed to effectively eliminate the nonconformance for implantable device. Assumed responsibilities for setting-up and troubleshooting of instruments in the manufacturing processes for Class II and III medical devices. Actively participated in audit line processes to maintain strict compliance with Quality Systems FDA CFR 820 and ISO 13485. Experienced in work with GLP and GMP regulations. Trained staff in regards to changes in the manufacturing processes and development of standard work, resulting in 4-fold production increase.

As an Engineering Technician, I performed a key role in the development of a candidate fluid test matrix for dielectric assessment, along with data analysis and interpretation to determine the best fluid for high-power microwave switches. Successfully generated thermal property testing to qualify fluids as per ASTM standards and effectively handled external testing to evaluate and authenticate results and reported to the Project Manager and the Director of Energy for a review. Utilized Fourier transform infrared spectroscopy (FTIR) in analyzing and defining additive concentrations in compliance with standard protocols. Established advanced instruction practices while performing constant process control evaluation to achieve a high-level quality. Determined the laboratory equipment for tests, and participated in maintaining equipment functionality, including troubleshooting and safety maintenance. Assumed responsibilities for generating up-to-date records of all incoming fluids as per specified requirements.