Manufacturing Engineer

Our client, a global hematology device company is currently seeking a Manufacturing Engineer to join their new state-of-the-art facility. This person will be responsible for developing and implementing changes to medical device product design and/or manufacturing process to achieve significant quality, cost, and reliability improvements. The Manufacturing Engineer will work cross-functionally with R&D, Quality and Regulatory to identify and fix manufacturability and testing issues and to ensure that the manufactured medical devices meet defined requirements.

Responsibilities:

  • Act as team member for large scale, complex, manufacturing projects to ensure successful manufacturing of medical devices through cross-functional collaboration with other business units, coordination of overall project and budget management
  • Ensure that production processes and systems as well as product designs for both existing and new products produce the highest possible quality and lowest possible cost
  • Responsible for driving and implementing multiple improvement programs and following-up on the results achieved, including Quality Monitoring and Actions, Production Efficiency, Improve Assembly Methods, Document and Implement Approved Changes
  • Communicate proactively, openly, and cooperatively within the department and with management team to keep team informed; provides oral reports, and prepares timely and clearly written status reports, updates, and technical presentations. May be the project leader on Lean/Six Sigma initiatives and Cost Improvement Projects, 5S, Kaizen events
  • Translates engineering requirements, and design specifications into the manufacturing space. Interfaces with customers, suppliers, application users, and other technical and support personnel to support efforts
  • Learns and applies standards, processes, policies, practices, techniques, and tools throughout the product/system development lifecycle including Standard Operating Procedures (SOP’s) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems

Qualifications:

  • Bachelor’s Degree in required, Chemical or Biomedical Engineering preferred
  • 2 – 5 years related experience in a manufacturing environment required, automated manufacturing experience preferred
  • Medical Device manufacturing experience
  • Knowledge of Six Sigma/Lean methods
  • Hematology experience preferred
  • Medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems preferred

 

If you are interested in this position, please send your resume to apowell@daleyaa.com

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