Job DescriptionPrimary Function of Position:Contribute your technical manufacturing, equipment design, process engineering, and project management skills to lead a dynamic and growing engineering team responsible for creating and implementing high volume manufacturing solutions for minimally invasive robotic surgery. The role requires strong leadership within the within the cross-functional organization to develop and launch automation systems, components, assemblies, process documentation, tooling and validation methods. Our objective is to implement novel automation and vertical integration solutions to enable better outcomes for more patients every day.
Roles and Responsibilities - Manager and their Team:- Lead and help grow a team of engineers to develop, implement, and sustain advanced manufacturing equipment and processes.
- Collaborate with multiple international teams 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.
- Lead 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.
- Analyze 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.
- Lead technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns. Utilize formal and informal techniques including fishbone, FMEA, etc.
- 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 financial aspects of the program, build financial models, and evaluate financial feasibility/impact of actions.
- Manage, coach, and mentor manufacturing, equipment, controls, etc. engineers
QualificationsSkill/Job Requirements:- BS degree in mechanical engineering or equivalent. MS preferred
- Minimum 5 years' experience process and/or manufacturing experience including automated production systems.
- Preference for candidate with strong electrical and/or controls background.
- Strong 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.
- Experience with process capability/statistical analysis of production and engineering metrics (cPK, SPC, etc).
- Prior experience designing and maintaining automated production equipment.
- Strong project leadership experience and experience launching new manufacturing into production.
- Experience managing suppliers to specific timelines and deliverables.
- 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.
- Role is 100% onsite, Sunnyvale California.
- Able to travel periodically to suppliers or Intuitive plants, including outside U.S. Travel is approximately 30%.
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
