Manager, Manufacturing Engineering

Intuitive • Sunnyvale, CA

107d

About The Position

Contribute your technical manufacturing, equipment design and project management skills to manage a dynamic engineering team responsible for creating and implementing high volume manufacturing solutions for minimally invasive robotic surgery. The role requires proven leadership within the within the cross-functional organization to develop and launch automation systems, components, assemblies, process documentation, tooling and validation methods. Our goal is to implement novel automation and vertical integration solutions to enable better outcomes for more patients every day.

Requirements

• BS degree in mechanical engineering or equivalent. MS preferred.
• 5-7 years' experience process and/or manufacturing experience including automated production systems.
• Proven written and verbal communication skills to interface and update technicians, engineers, and leadership on a regular basis.
• Prior responsibility for process, equipment or product validation/verification.
• Prior experience designing and maintaining automated production equipment.
• Proven project leadership experience and experience launching new manufacturing into production.
• CAD experience (preferred Solidworks).
• Spanish language proficiency is a plus.
• Industrial robot and/or PLC programming experience is a plus.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.

Responsibilities

• Manage a growing team of engineers to develop, implement, and sustain advanced manufacturing equipment.
• Partner with an international team to deliver product in a high-volume environment.
• Design and develop next generation manufacturing architecture utilizing internal and external resources.
• Create, maintain and improve mid- to high volume manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
• Apply experience in automation control and robot manufacturing systems to ensure designs and processes are capable (Yield/MTBF), serviceable (MTTR) and able to produce required throughput consistently (OEE).
• Utilize process design tools such as discrete event, PLC and robot path simulation to validate equipment designs prior to physical build.
• Manage design for manufacturing, design for automation, tolerance stack analysis, locator development and other inputs with cross functional team during product design.
• Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
• Parse manufacturing lines from a risk perspective (PFMEA) to develop protocols and validate critical tests used in manufacturing.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• Provide production line support for day-to-day engineering issues.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
• Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and engineering change implementation.
• Manage technical help examining and/or performing failure analysis for discrepant production components, assemblies and field returns.
• Function as single point of contact with equipment vendors, including business processes (contracts, POs, etc.) workload prioritization and escalations.
• Establish group and work goals consistent with overall product development goals.
• Assign tasks, set priorities, establish metrics, and track progress.
• Assess employee performance and provide coaching to improve performance.
• Manage, coach, and mentor manufacturing, equipment, controls, etc. engineers.

What This Job Offers

• Job Type: Full-time
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree