Manufacturing Engineer

The Staff Manufacturing Engineer supports contract manufacturers and suppliers in launching, scaling, and improving manufacturing processes for products. This role leads process validation, equipment development, cost improvement, and continuous improvement initiatives to ensure high-quality, efficient, and compliant production.

• Serve as the primary technical contact for contract manufacturers and suppliers
• Lead manufacturing process transfer from R&D to production
• Support supplier selection, qualification, and capacity planning
• Develop and execute process validations and documentation (IQ/OQ/PQ, PFMEA)
• Drive process improvements, yield improvement, and cost reduction projects
• Implement lean manufacturing tools (6S, Kanban, JIT, visual management)
• Develop manufacturing equipment, tooling, fixtures, and work instructions
• Lead new product introductions and design transfer to production
• Investigate product and process issues and implement corrective actions
• Ensure compliance with FDA, ISO, and quality system requirements
• Manage project schedules and timelines

• Bachelor’s degree in Mechanical Engineering or related field (Master’s preferred)
• 8+ years of manufacturing/process engineering experience (6+ with Master’s)
• Experience launching and transferring manufacturing processes, preferably in medical devices
• Strong problem-solving and statistical analysis skills (DOE, Cpk, Gage R&R)
• Experience with lean manufacturing and continuous improvement
• Experience in regulated environments (FDA, ISO, cGMP)
• Hands‑on experience with catheter, stent, or similar device manufacturing preferred
• Strong communication and project management skills
• Willingness to travel internationally as needed