Manufacturing Engineering
Artech Information Systems LLC
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.
Vacancy posted 2 days ago
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