Hiring: Sr Manufacturing Engineer – Medical Device
Location: Boulder, CO (Fully Onsite)
Type: W2 Contract | 12 Months
We are seeking a Sr Manufacturing Engineer to support PMO Operations Engineering projects focused on capital equipment implementation, process validation, manufacturing improvements, and cost-saving initiatives in a regulated medical device environment.
Key Skills Required:
• Project Management
• Manufacturing Engineering in a Regulated Environment (Medical Device preferred)
• Financial / Business Acumen
• Process Validation (IQ/OQ/PQ)
• Capital Equipment Installation & Commissioning
• Continuous Improvement & Lean Manufacturing
• Statistical Analysis, DOE & Minitab
• SOP Development & Document Control
Responsibilities:
• Lead cross-functional engineering and capital projects
• Manage project budgets, forecasting, and capital expenditures
• Support equipment procurement, installation, commissioning, and integration
• Execute process and equipment validations (IQ/OQ/PQ)
• Drive cost savings, capacity expansion, and operational improvement initiatives
• Troubleshoot manufacturing processes and equipment issues
• Collaborate with R&D, Quality, Operations, Supply Chain, and external suppliers
• Develop technical documentation, specifications, and SOPs
Qualifications:
• Bachelor’s Degree in Engineering
• 4+ years of Manufacturing Engineering experience
• Experience in Medical Device or other highly regulated industries
• Strong project management and process validation expertise.