Senior Process Engineer

Job Title: Sr. Process Engineer Department: Operations Direct Manager (Title): Head of US Operations and Manufacturing Office Location: Miami, Florida Job Summary: InspireMD is establishing a second manufacturing line in the United States and the person in this role will take the lead in managing the successful transfer of all equipment and processes from the InspireMD manufacturing site in Tel Aviv, Israel to a contract manufacturing organization (CMO) in the US. In addition to leading the transfer of all equipment and processes, this individual will become the US-Based Subject Matter Expert for all processes related to the manufacturing of the components and assembly for InspireMD products. Essential Duties and Responsibilities Process Knowledge and Equipment Transfer: Ability to quickly understand current processes related to InspireMD production equipment including knitting, stent crimping and loading and final assembly. Working knowledge of medical device component processing including nitinol laser cutting, injection molding, catheter processing, etc. Ability to identify critical process parameters and facilitate the IQ/OQ/PQ process validation activities with a contract manufacturing organization (CMO). Ability to identify and address inefficiencies in current processes to improve productivity and reduce costs. Utilize Six Sigma, Lean, and other process improvement methodologies to enhance process performance. Compliance & Quality Assurance: Ensure activities comply with all InspireMD quality requirements. Collaborate with Quality Assurance to address any deviations and implement corrective actions. Cross-Functional Collaboration: Work closely with R&D, Production, and Supply Chain teams to support the transition of new products from development to manufacturing. Provide technical support and training to the CMO to ensure a smooth operation and adherence to process standards. Data Analysis & Reporting: Prepare and present reports on product transfer, process improvement initiatives and project status to management. Project Management: Serve as the primary liaison between the CMO and the Tel Aviv team to ensure all transfer-related activities are properly addressed. Lead and participate in product transfer and process improvement projects, ensuring timely and successful completion. Manage project timelines and budgets to meet project objectives. Requirements (Relevant Education/ Languages, Skills) Ability to travel domestically and internationally (Europe and Israel) in order to understand current component and assembly equipment and processes. Travel 25-50%. Bachelor's degree in Mechanical Engineering or a related field. 5-10 years' experience as a Process/Process Development Engineer or equivalent in the medical device industry. Strong knowledge of manufacturing processes, equipment, and technologies specific to medical devices. Familiarity with FDA regulations, ISO 13485, and other industry standards. Proficiency in process improvement methodologies (Six Sigma, Lean, etc.). Excellent analytical, problem-solving, and project management skills. Strong communication and interpersonal skills, with the ability to work effectively in a team environment. #J-18808-Ljbffr

Created: 2025-01-14