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)