Manufacturing Engineer

Intuitive; Sunnyvale (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Intuitive in Sunnyvale, CA seeks a Mechanical Engineer to design, develop and deploy equipment testing and measurement systems for precision surgical instruments. You will collaborate with software teams to refine electro-mechanical components, ensure reliability, and drive cost improvements across high-volume production lines.

The role emphasizes qualification of equipment, root-cause analysis, and leadership in knowledge transfer and process DFx, with opportunities to travel to suppliers and

Qualifications

• Experience in mechanical design and analysis for high-volume manufacturing.
• Knowledge of quality and validation approaches (IQ/OQ/DQ/PQ) is preferred.
• Familiarity with PFMEA and manufacturing documentation practices.

Responsibilities

• Create and improve high-volume manufacturing lines, BOMs, workflows and work instructions.
• Design and qualify fixtures, tools, equipment, and related software components.
• Analyze equipment performance data to identify root causes and drive improvements.
• Support production lines and resolve equipment issues promptly.
• Lead continuous improvement projects to enhance yield and reduce cost.
• Ensure compliance with medical device quality systems and document changes.

Skills

Mechanical design

Analysis

Project management

Electro-mechanical systems

Control software

Root cause analysis

PFMEA

IQ/OQ/DQ/PQ

Manufacturing process improvement

Documentation

Leadership

SAP transactions

Tools

SAP

Job description

Job Description

Primary Function of Position

Contribute your mechanical engineering design and analysis skills to design, develop and deploy equipment to test, measure, and deliver quality instruments and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery.

The role requires active participation in the mechanical manufacturing engineering organization alongside our software engineering counterparts in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.

Essential Job Duties

• Create, maintain and improve "high-volume" 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 which includes hardware (mechanical and electronic components) and software (control algorithms and programming).
• Independently and proactively determines and analyzes data trends for equipment performance to root cause equipment issues to ensure accuracy, reliability, repeatability, and reproducibility of equipment.
• Modifies equipment drawings, orders, and implements to large scale production lines (cross plant, high volume)
• Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Responsible for (author, execution, and training) 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 i.e. resolve emergency and unscheduled problems/repairs of equipment.
• 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 of core instruments.
• Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
• Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
• Able to travel periodically to suppliers or Intuitive Mexicali plant
• Demonstrate leadership through knowledge transfer, mentoring, and training of others
• Proactively seeks better and improved technologies for improving production processes
• Improve existing documentation for equipment installation, repair, and upkeep.
• Responsible for review of peer edits to documentation of fixtures, tools, and equipment.
• Conduct SAP transactions relevant to process or equipment operations.