Manufacturing Engineer (Medical Devices)

Location: Pittsburgh, PA, United States; on-site

Annual salary: $90,000–$108,000

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including wearable defibrillators and heart failure monitoring systems.

What you will do

• Develop, validate, document, maintain, and support manufacturing processes, equipment, and process controls for electro-mechanical medical devices.
• Represent manufacturing engineering in new product development and support design transfers into production, including design for manufacturability, serviceability, and cost.
• Develop process flows, manufacturing standards, work plans, inspection plans, routers, and product drawing approvals.
• Create and execute manufacturing validation protocols, including IQ, OQ, PQ, TMV, and Gage R&R activities.
• Lead cross-functional FMEA, risk management, quality improvement, product transfers, and supplier problem-solving initiatives.
• Implement Lean/Six Sigma, cost reduction, waste elimination, process improvement, and ergonomic improvement projects.

Requirements

• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, or a related discipline, or equivalent experience.
• 4+ years of operations engineering experience in a manufacturing environment.
• Experience with ISO quality systems and regulated manufacturing environments.
• Experience with FMEA, control plans, risk management, process requirements, and structured problem-solving methods.
• Proficiency in Lean and process improvement tools, with the ability to communicate project status and work within cross-functional teams.
• Working knowledge of Microsoft Office, Microsoft Project, Minitab, and SolidWorks.

Culture & Benefits

• Work focused on improving outcomes for cardiac and cardiopulmonary patients.
• Innovation, self-motivation, and an entrepreneurial spirit are valued.
• Comprehensive employee benefits are available.
• Regular standing, walking, lifting, carrying, pushing, pulling, and repetitive motions are required.
• Working conditions may include occasional extreme temperatures, humidity, wet environments, and frequent noise.