Senior Mechanical Engineer, Medical Devices & Oxygen Systems

CAIRE Inc.; United States; A distancia; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

CAIRE Inc. in the United States seeks a Senior Mechanical Engineer responsible for design, development, and lifecycle support of oxygen concentrators and respiratory devices.

This role mixes hardware design with system integration and data-driven decision-making. You will lead DoE studies, lab testing, DV/PV activities, and coordinate across functions to ensure regulatory compliance, manufacturability, and robust performance.

Formación

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.
• 7+ years in product development, preferably medical devices.
• Experience with ISO 13485, IEC 60601/80601, and FDA design controls.

Responsabilidades

• 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 60601/80601, and FDA design controls.
• 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.

Conocimientos

Advanced Mechanical Engineering

System Integration

DoE / Experimental Design

Root Cause Analysis

Leadership

Cross-Functional Collaboration

Educación

Bachelor's or Master's in Mechanical Engineering

Herramientas

SolidWorks

CATIA

Descripción del empleo

CAIRE Inc. in the United States seeks a Senior Mechanical Engineer responsible for design, development, and lifecycle support of oxygen concentrators and respiratory devices.

This role mixes hardware design with system integration and data-driven decision-making. You will lead DoE studies, lab testing, DV/PV activities, and coordinate across functions to ensure regulatory compliance, manufacturability, and robust performance.