Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Manufacturing Engineer

Job Code: #546
Job Type: Contract
Salary: $50.00 - $60.00/hour
Job Location: Sturtevant, WI
Posted 4 days ago

Job Description

Title: Manufacturing Engineer (Medical Device)

Pay: $50.00 - $60.00/hour

Job Overview:  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.

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:

  • Identify potential suppliers and perform technical evaluation for selection.

Requirements:

  • Bachelor’s Degree in ME or EE or other relevant Engineering discipline
  • 3-7 years of related design and manufacturing experience in the medical device and/or component industry
  • Design Control experience including design and process verification and validation preferred
  • Injection molding, die casting, tooling experience
  • Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ)
  • Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis
  • SolidWorks or CAD experience preferred
  • Experience with Project Management
  • Practical knowledge of Six Sigma, Green or Black Belt
  • ISO Quality System requirements and FDA regulations knowledge required
  • Mechanical and electromechanical experience

Key Skills: IQ, OQ, PQ, Design, Process Development, Validation, ISO 13485, Engineering, Manufacturing, Medical Device, Component, Solid Works, Process, R&D, Statistics, FDA, Electromechanical