Mechanical Design Engineer

UST; Pune District; In loco; INR 900.000 - 1.200.000; Tempo pieno

Descrizione del lavoro

A medical technology company located in Pune District, India is seeking a Mechanical Engineer with over 8 years of experience in medical device mechanical design. The role involves designing and developing mechanical systems for ventilators and respiratory disposables, leading engineering and compliance activities, and collaborating with various teams. Ideal candidates have a strong background in pneumatic systems and proficiency with CAD tools like Creo. Competitive salary and professional growth opportunities are offered.

Competenze

• 8+ years in medical device mechanical design.
• Experience with ventilators or gas delivery systems preferred.
• Hands-on experience with CAD tools.

Mansioni

• Design and develop mechanical systems for ventilators and respiratory disposables.
• Lead sustenance engineering, remediation, and NPI activities.
• Execute CAPA child tasks and risk mitigation.

Conoscenze

Mechanical or Mechatronics Engineering

Medical device mechanical design

CPAP, BiPAP knowledge

Pneumatic systems

Strong CAD tools knowledge

Formazione

Bachelor's/Master's in Mechanical or Mechatronics Engineering

Strumenti

Creo/Pro-E

SAP

Windchill

ANSYS WB

Descrizione del lavoro

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)