Senior NPI Process Development Engineer

About the Company

Neptune Medical is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. The team is building Triton Robotic Endoscopy, a fully flexible medical robot designed to disrupt flexible endoscopy and set new standards in patient outcomes.

Responsibilities

• Work with product development to design and prototype novel manufacturing processes and equipment
• Develop new processes to meet device performance and cost targets
• Design and prototype novel manufacturing equipment and fixturing
• Create and maintain Manufacturing Process Instructions (MPIs), test methods, product drawings, and component specifications
• Upgrade manufacturing processes to ensure proper DFM and maximum scalability
• Initiate and implement programs to continuously improve quality, cost, and cycle time
• Prototype fixtures using 3-D printers, lathe, drill press, and band saw
• Provide technical support and perform failure analysis for non-conforming components and process defects
• Build the assembly line for clinical launches
• Manage WIP flow through Lean practices including Kanban and 5S
• Maintain relationships with key vendors and support supplier validations
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations

Requirements

• B.S. or M.S. in Mechanical or Related Engineering
• 4+ years of work experience
• Experience generating and managing manufacturing documentation (MPIs, LHRs, BOM, flowcharts)
• Proficiency in CAD modeling, engineering drawing generation, DFM, and tolerance analysis
• Knowledge of process validation, GMP, and state-of-the-art manufacturing processes
• Solid understanding of design controls
• Demonstrated success developing catheter manufacturing processes (braiding, coil winding, extruding, lamination, adhesive joining, die bonding, and laser welding)

Preferred Qualifications

• Experience with catheter manufacturing (lamination, bonding, dip coating, ultrasonic welding)
• Experience with disposables/consumables
• Experience managing lab technicians and assemblers
• Experience developing products from invention to market release
• Experience in a start-up environment
• Proficiency with SolidWorks
• Experience creating and managing schedules, budgets, and plans
• Experience with packaging and shipping validations