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Senior Manufacturing Engineer

2 months ago

Canberra, ACT, Australia JCSI Full time
Job Summary

The Senior Manufacturing Engineer will play a key role in the growth and support of Insulet's manufacturing operations. This individual will work on adding new manufacturing lines and equipment, as well as continuous improvement efforts for existing processes. The candidate will apply knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, contract manufacturers, and various teams within Insulet to ensure successful validation and performance of new and existing equipment and processes.

Responsibilities
  • Drive product and process improvements to support Insulet's operations
  • Deliver project results for new manufacturing equipment and upgrades
  • Support equipment validation and continuous improvement activities at Insulet manufacturing facilities
  • Own project phases from concept to implementation, including training and qualification
  • Monitor and report on yield and equipment up-time information, ensuring KPIs are at or above target
  • Develop and drive continuous improvement efforts
  • Generate validation protocols, coordinate execution, and write final reports
  • Analyze products using mechanical engineering methods
  • Use standardized root cause investigation templates and problem-solving tools
  • Implement corrective and preventive actions
  • Support new product introduction initiatives
  • Travel to suppliers for critical investigations or improvement projects
  • Maintain a quality system environment and operate within FDA guidelines
  • Author and implement Engineering Change Orders
Qualifications
  • 5+ years of manufacturing engineering experience in a medical device company
  • Medical device validation experience
  • Experience troubleshooting manufacturing equipment
  • Experience with automated equipment a plus
  • Experience with Minitab and/or JMP statistical analysis software, CAD or Solidworks, and Excel
  • Knowledge of Six Sigma/Lean manufacturing concepts
  • BS in Mechanical/Industrial/Electrical Engineering