Senior Process Engineer

Senior Process Engineer

Location: Charlotte, North Carolina

Work Arrangement: Hybrid (with regular visits to contract manufacturer and travel to Miami headquarters as required)

Inspire

MD 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 Inspire

MD'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 Inspire

MD products.

Inspire

MD 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.

• Quickly understand all equipment and processes related to the manufacturing of Inspire
  
  MD 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 Inspire
  
  MD 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

• 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

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.