Arbel Lichtenstein Email & Phone Number

Irvine, Ca, Us

Irvine, Ca, Us

Played a pivotal role in securing early FDA approval for a groundbreaking therapeutic for Tricuspid Regurgitation. Actively participated in implant audits conducted by DEKRA and the FDA. Cost Savings Initiatives: Reduced frame manufacturing costs by $5M, projected for 2025, by implementing a strategy and design verification plan. Aligned Irvine Implant Manufacturing's network of over 100 associates and operators to develop the internal capability for manufacturing Nitinol frames in-house at Edwards' facility.Complaint Resolution: Minimized engineering investigations on complaints by 90%, unlocking $0.5M in cost savings and liberating valuable time for engineers to focus on other critical tasks.Technical and Clinical Integration: Contributed as a key team member in the development of the Edwards TR system, integrating both technical and clinical inputs to ensure comprehensive solutions. Proactively identified issues from field or feasibility testing, conducted root cause analysis, and implemented solutions, advising leadership on the best course of action.Cross-Functional Collaboration: Worked with cross-functional teams, including Marketing and the Edwards Leading Team (ELT), to design Tricuspid implants and develop comprehensive testing protocols, including Design Verifications and Validations testing.Innovative Solutions: Designed jigs and fixtures, including Keyence routines, to support Verification and Validation packet manufacturing processes. Developed novel solutions to complex problems, ensuring they were simple, scalable, and minimized use errors.Product Development: Created, tested, and improved products by developing complex experiments and tests, including writing and executing protocols. Analyzed results, made recommendations, and developed reports based on engineering principles.

Tel Aviv, Il

A multifaceted role encompassing the research and development of a revolutionary alternative to traditional recycling. By harnessing the power of Artificial Intelligence (AI), we are developing a groundbreaking robot that purifies various inputs and transforms them into reusable raw materials.• Oversee the entire design process for the robot, including components, parts, assemblies, and subassemblies. This includes drafting, dimensioning, tolerancing, prototyping, and documenting results.• Ensure compliance with engineering design and performance specifications by directing necessary product modifications.• Develop and test models for alternative designs and processing methods to assess feasibility, explore new applications, and determine the need for modifications.• Draft performance requirements for engineering projects and product development.

Zofingen, Aargau, Ch

• Developed new products and processes that are competitive and meet all GMP and ISO requirements• Identified potential manufacturing process or product improvements to investigate, and develop efficient manufacturing methods and products• Tracked performance of process equipment or products by gathering, manipulating and analyzing data using standard techniques. Make recommendations and implement solutions• Stimulated process and products models for evaluation, improvements and enhancements• Interfaced with technicians and suppliers providing technical support as needed.• Assists in transferring technical and manufacturing processes to production floor.• Conceptualized and sketched process/product improvement fixtures. Coordinated the development and fabrication of these fixtures• Investigated and coordinated the resolution of deviations through comprehensive use of RCA tools• Devised and implemented CAPAs to address root cause and ensured effectiveness• Developed and performed IQ, OQ, PQ, and PPQ for validation and qualification• Coordinates and leads the activities and functions for new product technology transfer from customers to Siegfried• Providing product and process design input, defining specifications for equipment, selecting equipment suppliers, and locking down final commercial manufacturing process for customers.• Coordinate and facilitate transfer of product manufacture to additional CMO site(s)

Minneapolis, Mn, Us

Mazor Robotics an Israeli startup company which developed Mazor X & Renaissance robotic systems for spine and brain healthcare, acquired by Medtronic during 2018 for 1.64 Billion USD.• Development of multi-disciplinary medical robotic systems & surgical instruments, from the early stage of concept to fully commercial production.• Solving mechanical issues of the products and creating assembly line instructions and tests methods.• Establishing product requirements definitions.• Prototype assembly and testing, designing jigs for manufacturing in the assembly line or component testing.• Hazard assessment for variety of products conducting documents to support the product, all the work aligned with FDA regulations and ISO standards (ISO 10993).• Running root cause investigations and develop solutions to critique issues raised from the field.• Design using electrical schematics//mathematical models.• Integration with software and Medtronic navigation systems.

Jerusalem, Il

• Production processes optimization• Small series production• Project management• Material & processes characterization• Production processes familiarity• Acquisition processes

Tel Aviv, Israel, Il

Volunteered in a gifted children center as a coacher through their final technical projects

• Marketing supervisor, Managing the marketing crew of the company, logistics and executing transport to the Israeli market.• Technical work under water. • Operating heavy duty marine & offshore vehicles.

Tel Aviv, Il

Engineer’S Degree, Mechanical Engineering

Bachelor’S Degree, Marine Biology And Biological Oceanography