Manufacturing Engineer

Intuitive; Sunnyvale (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intuitive in Sunnyvale, CA is seeking an entry-level manufacturing engineer to support multiple Ion platform manufacturing lines, including mature and new instruments and accessories. The role emphasizes collaboration across Quality, Design, and Manufacturing to improve processes and lead line transfers.

You will help establish processes, develop fixtures, ensure GMP compliance, and mentor others as needed to enable transfers and reliable production.

Responsibilities

• Lead manufacturing line transfer projects across two plants.
• Procure, assemble, and qualify custom mechanical and electromechanical equipment.
• Improve equipment documentation and design for continuous improvement.
• Develop an in-depth understanding of manufacturing processes, and transfer knowledge to new engineers and assemblers remotely.
• Troubleshoot electromechanical equipment problems with third-party vendors as needed.
• Establish regular communication with the production team to support short and long term needs.
• Ensure GMP, design history file (DHF), and device history record (DHR) compliance per FDA requirements.

Job description

Job Description

Primary Function of Position

This entry level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform. This engineer must be able to support existing manufacturing lines, recommend and implement improved manufacturing processes, and lead manufacturing line transfers. The role requires the ability to collaborate effectively across functions ranging from Quality and Design to Manufacturing in the US and Mexico.

Essential Job Duties

• Lead manufacturing line transfer projects, including:
  • Lead project management effectively, including monitoring schedules for multiple functions across two plants
  • Procure, assemble, and qualify custom mechanical and electromechanical equipment
  • Improve equipment documentation and design as needed for continuous improvement in preparation for further transfers
  • Develop an in-depth understanding of our manufacturing processes, and transfer knowledge to new engineers and assemblers from a remote location to facilitate an effective transfer
  • Troubleshoot electromechanical equipment problems, including collaboration with third party equipment makers as needed, e.g. braiders, laminators, or testing equipment
• Support several Ion manufacturing lines including:
  • Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
  • Manage product reliability improvements from concept to implementation
  • Identify, design, qualify, document and introduce assembly/test fixtures and equipment
  • Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety
  • Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans
  • Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementations
  • Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders
  • Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
  • Provide technical support for failure analyses and root cause investigations of product failures
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress
• Provide resource budget estimates for product and process improvements, tooling development, and testing
• Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements