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Manufacturing Process Engineer

Location: San Jose, CA

Circulation

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.

Qualifications

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

 

 

Education/Training/Experience Requirements:

  • S. in Mechanical
  • 1-5 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.

 

  • Language Ability:

Ability to read, analyze, and interpret the most complex documents.  Ability to respond effectively to the most sensitive inquiries or complaints.  Ability to write speeches and articles using original or innovative techniques or style.  Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management.

 

  • Math Ability:

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.

 

  • Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

  • Computer Skills:

Working knowledge of desktop computer and software programs

 

  • Certificates and Licenses:

No certifications needed

 

 

  • Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

The noise level in the work environment is usually moderate.

 

  • Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is frequently required to travel.  The employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus. 

 

 

Preferred Experience:

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