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Intuitive · 3 months ago

Manufacturing Engineer - Process Development

Sunnyvale, CA

Full-time

Onsite

Entry, Mid Level

$121K/yr - $175K/yr

2+ years exp

Intuitive is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care. The Manufacturing Engineer - Process Development role involves contributing technical manufacturing and project management skills to create precision stapling instruments while ensuring compliance and continuous improvement in manufacturing processes.

Health CareManufacturingMedical Device

Growth Opportunities

No H1B

Responsibilities

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 on core instrument lines

Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction

Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability

Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation

Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns

Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions

Create, maintain, and improve manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions

Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment

Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing

Qualification

Mechanical EngineeringManufacturing EngineeringISO 13485CAD (SolidWorks)DFM AssessmentStatistical MethodsProject ManagementCommunication SkillsProblem SolvingTeam Collaboration

Required

Bachelors' degree in Mechanical Engineering or related technical discipline

2-5 years of experience as design or manufacturing engineer

Experience in mid/high volume manufacturing of complex mechanisms including SPC knowledge

High mechanical aptitude

Experience in DFM assessment and BOM development

Strong oral and written communication skills

Experienced in ISO 13485 medical device manufacturing environment

CAD experience (SolidWorks)

Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments, GR&R) in data analysis for process development and problem-solving

BS degree in Engineering discipline

Preferred

MS degree in Engineering preferred

Prior experience designing automated equipment or complex mechanism manufacturing

Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment

Skills in problem solving and using MiniTab, Python, SQL, Tableau and/or other SW tools for data analysis to identify root cause and drive corrective actions

Use of Agile or similar lifecycle management system tool

Sterilized medical device experience a plus

CAD experience (preferred Solidworks)

Able to travel periodically to suppliers or Intuitive manufacturing sites