• Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. • Utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.• Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.• Function as the Quality representative in new product development and lead in efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and statistical process control. • Develop a comprehensive risk management plan and ensure the delivery and utilization of effective quality strategies through all aspects of Design Control and Life Cycle Management of the product. • Ensure compliance with company policies and procedures while providing mentorship in the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDD, ISO standards, etc.). • Assist the team to ensure the application of design controls and product risk management as well as the investigation/correction of design failures/challenges and effective design control and transfer. • Collaborate with Manufacturing Quality Engineering to implement and supervise process capability measures prior to Design transfer.• Provide Lifecycle Management Support by providing accurate review and direction during change control and continuous improvement activities for changes that could affect the product design (form, fit, function and labeling requirements). • Ensures consistent application of Quality Engineering, Process Excellence/Six Sigma tools and techniques, including active and detailed investigation of quality issues and effective corrective and/or preventive action.

• Established the new product development capability to manufacture custom cranial-maxillofacial medical devices• Utilized Autocad to designed plant layout for better flow of the product during production• Experience with project management for project schedules, investment planning, budget, timeline, and other deliverables• Developed process documents, procedures, and work instructions for production/maintenance in compliance with ISO 13485:2016, CGMP & OSHA• Familiarity with performing process FMEA & control plans, root cause analysis, corrective and preventive actions in compliance with ISO 14971:2019• Executed cost reduction techniques, Statistical Process Control (SPC), and maintenance procedures to support the transition to sustainable production• Driving continuous improvement & optimization activities to meet production targets including availability, quality, and performance• Hands-on experience with 5-axis milling machine, 3D printers, laser machines, ultrasonic cleaning machines, etc.• Reduced Production lead time via implementation of lean six sigma concepts on the production line• Worked with a multi-disciplinary team for machining and cleaning validation (IQ, OQ, PQ) for the custom implant manufacturing process to ensure the compliance • Implemented lights-out manufacturing for running the 5-axis machine unattended with remote monitoring capability• Designed quick-change modular fixture design for easy set-up time and more accurate part mounting• Established relationships with external suppliers for contract manufacturing and support

• Participated in writing IQ, OQ, PQ, TMV validation protocols and reports• Participated with the team performing Risk Assessment, FMEA to identify root causes of problemsand present possible solutions• Design and conducted gage R&R studies• Used statistical tools such as Process Capability, Measurement System Analysis, and Statistical Process Control to assess and improve production processes• Creation of Data analysis, Technical Reports for waste reduction and increase the efficiency of theproduction• Generate documentation needed for the program, development activities, and (TMV)validation/verification testing activities• Writes, reviews, and approves technical documents and reports such as protocols, SOPs, filingdocumentation and other cGMP documents related to process validation• Experience with ISO 9001, ISO 14971:2012, ISO 13485:2016, and FDA, 21CFR820, EU MDR

• Reviewed electro-mechanical design drawings and updated Engineering Change Notice for Boeing ground support equipment• Suggest design modification with the client’s approval to develop the Bill of Materials (BOM) as per requirement• Read and interpret blueprints, technical drawing, schematics of Boeing aircrafts• Create 3D CAD modeling for Ground Support Equipments using SolidWorks®• Provided technical leadership to a small group of temporarily assigned engineers and technicians• Prototype building of VTOL aircraft with Additive Manufacturing• Analyze and planning workforce utilization, space requirements, workflow, and plant layout• Worked with the Manufacturing assembly line to support safety, production, quality, and continuous improvement projects• Worked on implementation of cost reduction and process improvement to ensure efficiency of operations and cost-effectiveness• Design, Analysis, and validation of Boeing 737 Nose Wheel landing gear in SolidWorks® through Reverse Engineering• Created deviation reports for mismatch and achieved 100% accurate results on time• Experience with Print reading, ISO 1101, and ASME Y14.5-2009 GD&T guideline to create parts and assembly drawing• Design and development of custom Jigs and fixtures• Experience with SolidWorks® Part Design, Assembly Design, Sheet Metal Design, Surface Modeling• Participated in concept development and validation, product design of all-electric cargo VTOL aircraft

• Conducted Process Planning and Work Breakdown Structure for a pipe fabrication process• Contributed in Bottleneck & Line balancing analysis for Value Stream Mapping• Time study performed for the Lean Six Sigma project to improve overall plant efficiency