R&D Manager, Mechanical Design

The R&D Manager, Mechanical Design will manage a group of engineers developing the drive mechanism and interface to robotic capital equipment for a novel robotic endoscopy system. The ideal candidate will act with passion and intensity in a medical device start-up that is fast paced and collaborative.

Requirements

• Manage 5-7 direct reports
• Work with product development to design and prototype novel manufacturing processes and equipment
• Design and prototype novel manufacturing equipment and fixturing
• Create and maintain necessary Manufacturing Process Instructions (MPI’s), test methods, product drawings, and component specifications
• Upgrade our manufacturing processes to ensure proper DFM and maximum scalability of our medical devices
• Initiate and implement programs to continuously improve quality, cost and cycle time
• Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
• Provides technical support and performing failure analysis for non-conforming components, assemblies, and process defects
• Build the assembly line for our clinical launches
• Manage the flow of WIP through Lean practices including Kanban and 5S.
• Maintain relationships with key vendors and suppliers and support supplier validations and supplier management best practices.
• Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure GMP.
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic regulations including Cal FDB, OSHA and Cal-OSHA.

Benefits

• 401(K) with matching