Manufacturing Engineer II

Job Title: Manufacturing Engineer II
Job ID: 26481
Location: 5920 Longbow Dr Boulder Colorado 80301 (Onsite)
Duration: 12 months
Pay Range: $45.00 - $50.00/HR. on W2

• Support PMO Operations Engineering team on MDR remediation, capital, and continuous improvement projects .
• Manage project schedules, budgets, forecasts, POs, capitalization, and financial tracking.
• Lead cross-functional teams to implement manufacturing, labeling, artwork, and process improvement projects.
• Execute equipment and process validations ( IQ, OQ, PQ ).
• Troubleshoot manufacturing processes, equipment, and production issues.
• Develop and maintain technical specifications, SOPs, and controlled documentation.
• Drive cost savings, capacity expansion, yield improvement, efficiency, and quality initiatives.
• Collaborate with R&D, Quality, Operations, Supply Chain, Suppliers, and Contract Manufacturers.

• Bachelor's Degree in Engineering.
• 2+ years of Manufacturing Engineering experience.
• Experience in a regulated industry (Medical Device preferred).
• Strong Project Management skills.
• Financial/Business Acumen (budgeting, forecasting, capital projects).
• Experience with process validation:
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
• Strong cross-functional collaboration skills.

• Medical Device manufacturing experience.
• MDR (Medical Device Regulation) project experience.
• Statistical analysis and validation methodologies.
• Capital equipment implementation.
• Continuous Improvement / Lean Manufacturing.
• Supplier and Contract Manufacturer management.