Senior Mechanical Engineer - Medical Devices & Systems

CAIRE Inc.; Canton (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

CAIRE Inc. seeks a Senior Mechanical Engineer to lead the design and development of oxygen concentrators and respiratory devices.

You will own the mechanical architecture, drive performance, and coordinate hardware, controls, and software interfaces across global teams. The role requires hands‑on lab work, DoE, DV/PV activities, and rigorous documentation to meet ISO 13485, IEC 60601/80601, and FDA design controls.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.
• 7+ years of experience in product development, preferably medical devices.
• Strong experience in mechanical system design, hands-on testing, and CAD tools.

Responsibilities

• Lead the design and development of oxygen concentrators and respiratory devices, including compressor subsystems, pneumatics, flow paths, filtration, and enclosures.
• Define and optimize the mechanical architecture and mechanical integration across hardware, controls, and software interfaces.
• Drive performance attributes including flow, pressure, oxygen purity, acoustics, thermal management, and durability.
• Apply design for reliability, manufacturability (DFM), assembly (DFA), serviceability, and cost (DTC) principles.
• Design and execute structured experiments (DoE) to understand system sensitivities and optimize performance.
• Lead hands‑on lab testing, feasibility studies, and root cause investigations for complex system issues.
• Develop and validate engineering test methods, fixtures, and data acquisition approaches.
• Analyze data using statistical tools to drive evidence-based engineering decisions.
• Plan and execute design verification and validation (DV/PV) activities, ensuring compliance with ISO 13485, IEC 60601 / IEC 80601, FDA and global regulatory requirements.
• Support risk management activities (FMEA, hazard analysis) and ensure traceability from requirements to verification.
• Partner with Electrical, Systems, Software, Manufacturing, Quality, and Supply Chain teams to ensure integrated product performance.
• Collaborate with global teams to align designs, test methods, and system performance.
• Interface with suppliers to develop critical components and ensure technical readiness.
• Support product launches and scale‑up, resolving issues from prototype through production.
• Lead failure analysis and corrective actions for field and production issues.
• Drive continuous improvement in yield, reliability, and cost.
• Create and maintain design documentation, test reports, and engineering analyses.
• Contribute to engineering standards, work instructions, and best practices.
• Mentor junior engineers and elevate team technical capability.

Skills

Mechanical system design

Hands-on testing

Statistical analysis

Cross-functional collaboration

Design of Experiments (DoE)

Education

Bachelor’s or Master’s in Mechanical Engineering

Tools

SolidWorks

CATIA

DAQ systems

Job description

CAIRE Inc. seeks a Senior Mechanical Engineer to lead the design and development of oxygen concentrators and respiratory devices.

You will own the mechanical architecture, drive performance, and coordinate hardware, controls, and software interfaces across global teams. The role requires hands‑on lab work, DoE, DV/PV activities, and rigorous documentation to meet ISO 13485, IEC 60601/80601, and FDA design controls.