Manufacturing Engineer

ENEA Software & Services - Phoenix, AZ (30+ days ago)


Manufacturing Engineer--Sustaining Engineering

Primary Location: Mesa, AZ Schedule: Full time

Travel: up to 25% Duration: 2+ years

ENEAan environment where you can innovate.

We are seeking a Manufacturing Engineer to work on a 2+ Year LONG TERM contract working on medical devices in Mesa, AZ (East of Phoenix).

The Manufacturing Engineer is a manufacturing and process development expert leading project work related to manufacturing integration of medical devices.

This individual will be involved in all phases of product development as a key contributor representing manufacturing.

You will work with R&D to ensure designs are manufacturable, evaluate potential suppliers, and work with internal and external teams to develop and validate manufacturing processes.

Essential Duties & Responsibilities

  • Process Development & Validation
  • Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
  • Develop & define production control methods to monitor process output and establish critical supplier metrics.
  • Define and coordinate the design and development of manufacturing fixturing and test equipment.
  • Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
  • Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.
  • Lead and support manufacturing development and transfers to contract manufacturers.
  • Design Controls Documentation
  • Provide input to the User Requirements and System Requirements Documents.
  • Ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
  • Supplier Evaluation & Selection
  • Identify potential suppliers & perform technical evaluation for selection
  • Develop the team
  • Guide work & mentor junior team members
  • Other duties as assigned

Job Related Qualifications/Skills

Education:

  • Bachelor’s Degree in Mechanical or Electrical Engineering or other relevant engineering discipline REQUIRED

Professional Experience Required:

  • 3-7 years of related design and manufacturing experience in the medical device industry ***HARD REQUIREMENT—MUST HAVE PREVIOUS MED DEVICE EXPERIENCE**
  • Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ)

Professional Experience Preferred:

  • Design Control experience including design and process verification and validation
  • Injection molding, die casting, tooling experience

Knowledge, Skills, & Abilities (incl. languages)

  • Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis
  • SolidWorks or other CAD experience
  • Familiar with project management methods and tools

Knowledge of Methods

  • Practical knowledge of Six Sigma methodologies. Green or Black Belt certification preferred
  • Understanding and application of ISO Quality System requirements and FDA regulations
  • Familiar with a variety of manufacturing processes including mechanical and electromechanical

Personal Skills

  • Ability to work effectively with internal and external teams
  • Demonstrated ability to deliver results with minimal supervision
  • Ability to support and direct the efforts of junior level engineering staff

Job Types: Full-time, Contract

Salary: $55.00 to $65.00 /hour

Experience:

  • SolidWorks or other CAD: 3 years (Required)
  • Manufacturing Engineering in Medical Device Industry: 3 years (Required)
  • manufacturing & assembly process development & validation: 3 years (Required)

Education:

  • Bachelor's (Required)

Work authorization:

  • United States (Required)