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 Engineering4 - 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