Mehanical Engineer

Roles and Responsibilities:

• Design mechanical components and assemblies for ventilators and other respiratory therapy devices.
• Identify and define Critical to Safety (CTS) and Critical to Quality (CTQ) parameters during design and development.
• Create and maintain Bill of Materials (BOM) with accurate part specifications, revisions, and sourcing details.
• Develop 3D models, detailed drawings, and tolerance analyses using CAD tools.
• Perform simulations (thermal, structural, fluid flow) to validate mechanical integrity and performance.
• Update and maintain engineering drawings and design documentation in accordance with change control procedures.
• Support creation and maintenance of DHF elements including design outputs, verification records, and risk mitigations.
• Support mechanical verification testing including vibration, drop, thermal, and ingress protection.
• Collaborate with V&V and risk teams to ensure mechanical components meet safety, reliability, and regulatory requirements.
• Work closely with systems, electrical, software, and quality teams to ensure mechanical design aligns with system architecture.
• Participate in design reviews, risk assessments, and change control boards.

Education & Skills preferred:

• MTech / ME / BE / BTech in Mechanical/production Engineering
• 4 - 6 years of experience in product design and development for medical systems & components.
• Experience with ventilators, CPAP, BiPAP, or similar life-support systems is highly preferred.
• Proficient in CAD tools (e.g., SolidEdge, SolidWorks, Creo, CATIA).
• Experience in simulation tools (e.g., ANSYS, SolidWorks Simulation) will be added advantage.
• Strong understanding of CTS/CTQ identification and traceability.
• Certification in medical device design, GD&T, or quality systems is desirable.

Strong analytical, documentation, and communication skills

Job Location-Pune

Exp -3+years

Notice Period-upto 45days