Senior Manufacturing Engineer
On-siteSunnyvale, California, United States
Job Summary
Establish and develop manufacturing processes for new product development accessories while providing daily support for manufacturing operations and mechanical design improvements. Design, document, and qualify fixtures, tools, and equipment; analyze manufacturing lines using PFMEA to validate critical tests. Create and refine pilot mid-to-high volume assembly lines, specifying BOMs, workflows, and detailed work instructions. Provide production support through project launch, implement continuous improvement projects for yield and cycle time, and offer product and process DFx input. Maintain compliance with medical device quality systems, including corrective actions and ECOs, while providing technical support for failure analysis on discrepant components and field returns.
Required Qualifications
- BS / MS degree in Engineering discipline or equivalent work experience
- 5-10 years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content
- Prior responsibility and experience with process development and process parameter development (DOE, critical parameter management)
- Experience with equipment selection, test method development, and working closely with equipment/automation vendors
- Experience with product and process validation & verification, specifically in a medical device or similarly controlled industry
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams
- Great attitude, eager, willing/able to take initiative, works well with others in team environment
- Able to travel periodically to suppliers or Intuitive Mexicali plant
- show current proof of vaccination against certain diseases including COVID-19
Desired Qualifications
- CAD experience (preferred Solidworks)
- New product introduction/development desirable
- Robotics knowledge a plus
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
- Prior experience designing automated equipment, complex mechanism manufacturing is a plus
- Experience with catheter manufacturing processes and leak test development a plus
- Experience with high volume automated assembly and plastic forming (injection molding, transfer molding) and joining processes (laser welding, ultrasonic welding, heat staking) a plus
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