Senior Manufacturing Engineer

The Senior Manufacturing Engineer supports the development, qualification, and launch of new and updated medical devices. This role involves working with various departments to ensure efficient design transfers and success in cross-functional teams. With a background in lean manufacturing and relevant product knowledge, the Manufacturing Engineer improves processes and explores new ideas.

RESPONSIBILITIES :

• Design and optimize manufacturing processes, procedures, and production layouts for drug-device products.
• Enhance drug coating processes and equipment, prioritize improvements, and implement innovations.
• Assist with project timelines and development plans.
• Coordinate with teams for new product designs and updates, and provide training.
• Participate in PFMEA, DFMEA, Process Mapping, and CTQ reviews.
• Lead or support Design for Manufacturing (DFM) activities.
• Create and review process flow charts, tooling strategies, line layouts, capacity analyses, and EHS plans.
• Manage line validation and qualification activities, including IQ, OQ, MSA, and PQ.
• Engage in Lean initiatives to improve production line stability and reduce transfer time.
• Enhance manufacturing efficiency through workflow analysis, time studies, space planning, and equipment layout.
• Write and oversee testing protocols and analyze product evaluation requests.
  Develop process documentation, including Work Instructions and Control Plans.
• Ensure quality by designing testing methods and establishing manufacturing standards.
• Provide decision-making information on costs, production schedules, and future needs.
• Prepare and summarize reports on product and process information.
• Comply with Laborie QMS, ISO 13485, and other relevant standards.
• Ensure equipment functionality by managing maintenance, repairs, and special services.

QUALIFICATIONS REQUIRED :

• Master’s or Bachelor’s degree in Mechanical Engineering or related field with relevant experience.
• Experience in lean manufacturing, ISO 13485/ISO 9001, medical device environments, manufacturing quality, and project management.
• Knowledge of Design for Manufacturability (DFM), Six Sigma Green Belt, and Lean Six Sigma.
• Experience with ERP systems.
• 5% domestic and/or international travel potential.