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. Key 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 (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. Cultural & Behavioral Expectations
• 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. Competencies
• 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 Design of Experiments (DoE) in product development
• Familiarity with flow, pressure, and gas separation systems (PSA preferred)
• Experience with test system development and automation
• Knowledge of manufacturing processes (injection molding, machining, assembly systems)
• Experience with Six Sigma / statistical quality methods Work Environment & Physical Demands
• Combination of office and hands-on lab/testing environment
• Regular interaction with mechanical systems, test fixtures, and prototypes
• Occasional lifting up to 50 lbs and travel as needed Travel Limited as needed Required Education and Experience
• Bachelor’s or Master’s degree in Mechanical Engineering or related field
• 7+ years of experience in product development, preferably in medical devices or regulated industries
• Strong experience in:
• Mechanical system design (pneumatics, flow systems, compressors preferred)
• Hands-on testing, lab work, and experimental methods
• CAD tools (SolidWorks, CATIA, or equivalent)
• Statistical analysis and engineering data interpretation
• Working knowledge of ISO 13485, IEC 60601 / 80601, and FDA design controls Preferred Education and Experience
• First-hand knowledge and experience of common manufacturing processes such as injection molding, die casting, machining, etc.
• First-hand knowledge and experience with simulation modeling (i.e. finite element analysis)
• Understanding of manufacturing factory metrics and Six Sigma principles.
• Understanding of Medical Device design control processes and associated ISO standards compliance (60601, 13485, etc.) preferred
• Awareness and understanding of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 9001 knowledge and experience preferred. Additional Eligibility Qualifications None required for this position. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.