Sorin Gorgan Email & Phone Number

Torrance, CA, US

Santa Monica, California, US

• 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.
• 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.

Los Angeles, California, US

• 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.
• 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.

Los Angeles, California, US

• 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.

Minneapolis, MN, US

• 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.
• 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.

Minneapolis, MN, US

• 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.
• 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.

Minneapolis, MN, US

• 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.
• Spearheaded the entire project lifecycle, from development to 510K submission and IEC testing, ensuring regulatory compliance and successful product launch.

Torrance, California, US

• 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.

Master Of Business Administration (Mba), Executive Management

Diploma, Mechanical Engineering (Mechatronics)