Tasked with the establishment of operational divisions and protocols, including Manufacturing, Supply Chain, Quality, Site Installation, and Service, for Celestial Oncology, a manufacturer of Class II radiation therapy devices.● Successfully implemented the company's QMS and ERP system (QT9), providing comprehensive training for seamless integration.● Authored essential documents, including SOPs, DWIs, and Level 3 documents, covering various operational aspects.● Conducted supplier assessments and managed NDAs for custom component design.● Collaborated with R&D to optimize product designs for smoother production processes.

I transitioned to NovaSignal on a full-time basis, where I led production, sustaining and manufacturing engineering, facility operations, and ensured OSHA compliance in Class II Medical Device Manufacturing. My role also included upholding ISO 13485 standards.● Led the design and implementation of innovative systems, policies, and procedures, resulting in operational efficiency.● Took charge of recruiting and training production operators and engineers, equipping them with the skills needed to proficiently assemble complex robotic systems.● Formulated quarterly Objectives and Key Results (OKRs) and established monthly Key Performance Indicators (KPIs), ensuring rigorous progress monitoring, and driving continuous improvement.● Directed daily 15-minute operations meetings, fostering collaboration among team members, Supply Chain, Quality Assurance, and Engineering representatives.● Orchestrated weekly Output Maximization (OutPut Max) meetings with sales and internal operations, enhancing supply visibility and effectively meeting demand. ● Successfully oversaw Phase 5, ensuring the seamless transition to the production phase and comprehensive validation of new products (IQ, OQ, PQ, MSA, and PFMEA).

I consulted with NovaSignal to establish a cutting-edge Class II medical device manufacturing facility in compliance with FDA and CE standards. ● Successfully hired and mentored new employees for all operations, established policies, and training systems.● Set up a state-of-the-art manufacturing facility.● Played a pivotal role in creating a streamlined and efficient supply chain, optimizing procurement and distribution processes. Oversaw raw material and subassembly levels for $3M inventory.● Authored and implemented Standard Operating Procedures (SOPs) and Detailed Work Instructions (DWIs) to guide various aspects of the manufacturing process, ensuring consistency and compliance.● Established a dedicated service group to provide field support for NovaSignal's released products, enhancing customer satisfaction and product reliability.● Collaborated closely with the Research and Development (R&D) team to optimize product designs for manufacturability, contributing to smoother production processes and cost efficiency.

In my managerial role, I guaranteed the seamless flow of products, managed the introduction of new products (NPI), upheld reliability standards, and spearheaded continuous improvement efforts for items produced at the Los Angeles site, specifically focusing on the GI Manometry product line.● Led cost-saving initiatives, resulting in substantial annual savings of $470k through sourcing optimizations.● Ensured compliance with Unique Device Identifier (UDI) standards in Culver City and Vietnam.● Supervised a team of nine engineers, supporting manufacturing and sustaining operations.● Improved A3 sensor yield from 92% to 98% within six months.● Represented the company as SME for the yearly TUV audits.● Facilitated international collaboration with subsidiaries in Vietnam and Israel.● Co-invented the AR compliance balloon (US20170128012A1).

As a promoted manager at Given Imaging, a division under Covidien, I directed the sustaining engineering group in both Los Angeles and Vietnam. In this role, I supervised the transfer of products to international subsidiaries in Vietnam and Israel and spearheaded projects for five product lines, including the Versaflex-Z catheter, vital for monitoring reflux in GERD patients.● Managed the transfer of products to OUS subsidiaries (Vietnam and Israel) in the medical device manufacturing sector.● Achieved substantial annual savings of $1.5 million through successful product transfers.● Implemented cost-effective production floor improvements to enhance efficiency.● Led a critical project involving five additional product lines for GERD patient monitoring.● Proficiently handled SRs, CAPA, and secured Engineering Change Order (ECO) approvals.● Collaborated closely with Sales & Marketing to address customer concerns.● Oversaw company relocations, including layout design and infrastructure setup for a 25,000 sq. ft. facility, compressed air line installation, and a specialized nitrogen line for core products

In the role of a Product Development Engineer, I oversaw the entire spectrum of new product development, ranging from initial research to seamless integration into production. ● Led the development of critical projects involving high-resolution impedance catheters, electronic modules (A200, A400, A500/A510), accessory kits such as ManoShield, calibration chamber, peripherals, and a medical modular cart system.● Spearheaded the entire project lifecycle, from development to 510K submission and IEC testing, ensuring regulatory compliance and successful product launch.

𝙈𝙮 𝙎𝙞𝙜𝙣𝙖𝙩𝙪𝙧𝙚 𝘾𝙤𝙣𝙩𝙧𝙞𝙗𝙪𝙩𝙞𝙤𝙣𝙨 𝙄𝙣𝙘𝙡𝙪𝙙𝙚:● Created, updated, and corrected Bill of Materials (BOM) using Solid Works, AutoCAD, and Corel Draw.● Engaged with the OUS team in China and Germany to improve the quality of existing or new products.