Staff Manufacturing Engineer, New Product Introduction

Intuitive • Sunnyvale, CA

17h

About The Position

Primary Function of Position The Staff NPI Manufacturing Engineer in Intuitive Surgical’s Future Forward group will support the development of manufacturing processes and equipment for endoscopes, instruments, and/or accessories for a new robotic surgical platform. As an early member of the team, this role will help define the eventual product from early prototypes through clinical trials and into product launch.

Requirements

• Minimum 6 years’ experience, at least 2 years in medical device manufacturing
• Ability to leverage internal and external resources to complete tasks
• Experience with validation/verification of processes, equipment, and products
• Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design
• Quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk
• Familiarity with mechanical CAD (Solidworks), ERP (SAP), PLM (Agile), and ALM (Polarion) software
• Strong organizational skills and proven ability to work on multiple fast-paced project threads simultaneously
• Clear and efficient documentation skills
• BS in relevant engineering discipline

Responsibilities

• Assess manufacturability of current designs and identify critical steps for further process development
• Develop NPI strategy for supporting verification and validation of product
• Build and maintain top level assemblies in Agile document control system
• Define pilot manufacturing lines for system components, instruments, and accessories, order equipment, and bring up the line
• Design, specify, purchase, build, and qualify aids and test equipment for the line as necessary
• Manage completion of all manufacturing documentation in support of launch
• Support pilot line builds of product for early feasibility studies

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level