Mechanical Design Engineer
UST
2 - 5 years
Pune
Posted: 05/03/2026
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Job Description
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
- Bachelors/Masters 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 injectionmolded parts
- GD&T (ASME Y14.5), tolerance analysis
- Handson experience with CAD tools (Creo/ProE preferred)
- Exposure to CFD, FDA, ISO 13485, 21 CFR Part 820 (preferred)
- Tools knowledge: SAP, Windchill, ANSYS WB (plus)
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