Mechanical Design Engineer

Key Responsibilities

• Design and develop mechanical systems for ventilators and respiratory disposables (masks)
• Lead sustenance engineering, remediation, relaunch, and NPI activities
• Execute CAPA child tasks, RCA, FMEA, and risk mitigation
• Support MDD/MDR & EU MDR compliance and DHF remediation
• Own mechanical subsystems (gas path, valves, sensors, blowers, motors, enclosures)
• Perform verification and validation testing in the lab
• Create and review design documentation, drawings, test plans, and reports
• Collaborate with PMG, Manufacturing, Quality, and Regulatory teams
• Support production, troubleshooting, and sample builds

Required Skills & Experience

• Bachelor’s/Master’s in Mechanical or Mechatronics Engineering
• 8+ years in medical device mechanical design
• Experience with CPAP, BiPAP, ventilators, or gas delivery systems (preferred)
• Strong knowledge of:
• Pneumatic systems, pressure & flow sensing
• Gas valves, blowers, plastic injection‑molded parts
• GD&T (ASME Y14.5), tolerance analysis
• Hands‑on experience with CAD tools (Creo/Pro‑E preferred)
• Exposure to CFD, FDA, ISO 13485, 21 CFR Part 820 (preferred)
• Tools knowledge: SAP, Windchill, ANSYS WB (plus)