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Senior Manufacturing Engineer

Location: San Jose, CA

Temperature Management

Overview

General Summary:

The position is responsible for developing, implementing, and validating processes and procedures to manufacture electromechanical and catheter-based medical devices in full compliance with the company’s quality system.  Apply Lean concepts to reduce waste and maximize efficiency.  Troubleshoot production issues.  Work with vendors to drive cost reductions to existing components and assemblies.

Responsibilities

Essential Functions:

  • Works closely with R&D engineers during the product design phase to ensure Design for Manufacturability requirements are considered and implemented. Understands the product design to implement and improve manufacturing processes.
  • Develops and improves existing manufacturing methods, fixtures and assembly aids.
  • Analyzes and documents workflow. Works with production to layout equipment and workspace for maximum efficiency.
  • Works with vendors to address issues and to identify opportunities to reduce cost. Coordinates efforts with Supplier Quality Engineer.
  • Troubleshoots production issues and implements appropriate solutions. Uses DOE techniques to characterize and improve processes and production yields.
  • Creates verification and validation test protocols and reports including equipment IQ/OQ/PQ as required.
  • Dispositions Non-Conformance Reports and Corrective and Preventive Actions as assigned.
  • Trains Operators on new or modified processes.
  • Ensures all production equipment is properly calibrated and maintained.
  • Facilitates communication between all team members.
  • Provides leadership, direction, and ownership in areas of manufacturing engineering and process development.
  • Performs and documents Process Failure Modes and Effects Analysis as needed.
  • Performs other tasks as assigned by their supervisor.

 

Skill Requirements:

  • Attention to detail
  • Excellent problem solving skills
  • Solid background in electrical, mechanical, and/or materials engineering
  • Excellent written and verbal communication skills
  • Self-directed
  • Effectively prioritizes and manages the completion of multiple projects
  • Able to collaborate effectively in cross-functional teams
  • Able to use Solid Works or Pro-E to document fixtures and assembly aids

Qualifications

Education/Training/Experience Requirements:

  • BS in Mechanical Engineering
  • 5-9 years manufacturing engineering experience, preferably in a regulated environment
  • Experience with Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA)
  • Solid Works experience a plus. 

 

Preferred Experience:

  • Medical device manufacturing involving electromechanical and/or catheter-based products
  • Lean methodologies
  • FDA, ISO

Equal Opportunity Employer – Disability and Veteran

 

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