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

Mehanical Engineer