Manufacturing Engineering

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
Core Responsibilities

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.
Must-Have Skills

• 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.

Preferred 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.