Manufacturing Engineer II
Artech Information Systems LLC
Manufacturing Engineer II
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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