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The Manufacturing Engineer, OR1 supports manufacturing operations, new product launches, and continuous improvement initiatives for the OR1 product portfolio. This role partners cross-functionally with Engineering, Manufacturing, Quality, and Global Supply Chain teams to improve operational efficiency, product quality, and cost effectiveness.
Job Responsibility:
Support new product introductions through process design, tooling validation, SOP creation, and manufacturing readiness activities
Evaluate product designs for manufacturability and support Make-or-Buy decisions
Troubleshoot production and field issues, perform root cause analysis, and support supplier quality initiatives
Drive continuous improvement projects utilizing Lean, JIT, and 5S methodologies
Improve production flow, tooling, equipment layouts, and operational processes
Support obsolescence management and cost reduction efforts
Train manufacturing personnel on processes and procedures
Partner with internal teams and external vendors to ensure successful product transfers and operational execution
Requirements:
Bachelor's degree in Industrial, Mechanical, or Electrical Engineering
7+ years of manufacturing engineering experience
Experience with Lean manufacturing, 5S, and continuous improvement initiatives
Knowledge of mechanical and electrical assembly manufacturing processes
Proficiency with Microsoft Office Suite and SolidWorks
Strong analytical, troubleshooting, communication, and collaboration skills
Familiarity with FDA, ISO 13485, and ISO 9001 quality standards
Nice to have:
Master's degree in Engineering
Lean or Six Sigma certification
Experience in medical device manufacturing and systems integration
10+ years of manufacturing engineering experience
What we offer:
Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave
401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution