Senior Process Engineer

InspireMD•Charlotte, NC

8d•Hybrid

About The Position

InspireMD is establishing a second manufacturing line in the United States for the CGuard Prime product, which has recently launched in the United States. The person in this role will lead all manufacturing process improvement and capacity expansion initiatives at InspireMD's contract manufacturer in Charlotte, North Carolina. Additionally, this individual will become the US-Based Subject Matter Expert for all processes related to the manufacturing and assembly of InspireMD products. InspireMD headquarters is located in Miami, Florida, and the manufacturing location is Charlotte, NC. This position offers a hybrid work arrangement with regular visits to our contract manufacturer as required, as well as travel to Miami to interface with the Miami-based leadership team. This is a pivotal role for a growing medical device company expanding its US manufacturing capabilities. You will have the opportunity to shape manufacturing processes from the ground up, work with cutting-edge medical device technologies, and make a direct impact on product quality and company growth. If you're an experienced process engineer looking to take on a leadership role and drive meaningful improvements in a dynamic environment, we want to hear from you.

Requirements

Bachelor's degree in mechanical engineering with strong mechanical acumen
Proven experience as a Product or Process Development Engineer in the medical devices industry with a minimum of 8 years' experience
Strong knowledge of manufacturing processes, equipment, and technologies specific to medical devices
Experience working closely with product development teams to provide Design for Manufacturing (DFM) guidance
Familiarity with FDA regulations, ISO 13485, and other industry standards
Proficiency in process improvement methodologies such as Six Sigma and Lean
Excellent analytical, problem-solving, and project management skills
Strong communication and interpersonal skills with the ability to work effectively in a team environment
Ability to travel domestically and internationally (Europe and Israel) to understand current component and assembly equipment and processes, approximately 25-50% travel as needed

Responsibilities

Quickly understand all equipment and processes related to the manufacturing of InspireMD products including catheter processing and assembly, mesh knitting, stent crimping, final assembly, and more
Maintain working knowledge of medical device component processing including nitinol laser cutting, injection molding, catheter processing, and related technologies
Identify and address inefficiencies in current processes to improve productivity and reduce costs
Work collaboratively with our contract manufacturing partner to lead process and continuous improvement initiatives
Utilize Six Sigma, Lean, and other process improvement methodologies to enhance process performance
Ensure all activities comply with InspireMD quality requirements
Collaborate with Quality Assurance to address any deviations and implement corrective actions
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 smooth operation and adherence to process standards
Prepare and present reports on product transfer, process improvement initiatives, and project status to management
Serve as the primary liaison between the CMO and the Tel Aviv team to ensure all manufacturing process-related activities are properly executed
Lead and participate in product transfer and process improvement projects, ensuring timely and successful completion
Manage project timelines and budgets to meet project objectives