Sr. Mechanical Engineer

Summary / Objective The Senior Mechanical Engineer is a key technical contributor responsible for the design, development, and lifecycle support of oxygen concentrators and respiratory therapy devices. This role combines deep mechanical engineering expertise with system-level thinking, hands‑on lab work, and data-driven decision-making. This engineer operates at the intersection of hardware, systems integration, and product performance, driving robust, cost-effective, and regulatory-compliant solutions.

The role requires a proactive, technically curious, and detail-oriented problem solver who thrives in ambiguity, actively investigates root causes, and uses structured engineering methods such as Design of Experiments (DoE), verification testing, and feasibility studies to inform decisions.

• 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 (e.g., Chengdu) to align designs, test methods, and system performance.
• Interface with suppliers to develop critical components (e.g., compressors, valves, molded parts) 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.

• Proactive Ownership:
  Anticipates issues, takes initiative, and drives solutions without waiting for direction.
• Technical Curiosity:
  Actively explores how systems work; seeks data and understanding, not assumptions.
• Hands‑on Problem Solver:
  Comfortable in the lab; validates ideas through testing, not theory alone.
• Diligence & Rigor:
  Applies structured engineering methods (DoE, root cause analysis, statistical thinking).
• Collaborative Mindset:
  Works effectively across functions and global teams with clarity and respect.

• Advanced Mechanical Engineering & System Integration
• Experimental Design & Statistical Analysis (DoE)
• Root Cause Analysis & Problem Solving
• Product Development Lifecycle Management
• Cross-Functional Leadership
• Communication & Technical Documentation
• Experience with oxygen concentrators, respiratory devices, or compressor systems (WOB-L, scroll, etc.)
• Experience applying…