Project Manager (Medical Devices/ Medical Equipments Domain)

Responsibilities:

·         Set up the engineering team and develop new products as per customer SOW Establish strong relationships with customer Will be accountable for ensuring that development projects achieve Cost and Quality objectives and are executed in the right time.

·         Develop the design process, which will include mechanical design, process design, validation and documentation. Set up Key Performance Indicators (KPIs), measure and monitor performance of the processes, analyze and report the performance measures.

Detailed Domain Knowledge:

−    Medical industry domain must either from OEM or Competition companies involved in medical device mechanical design.

−    Knowledge of Medical Regulatory compliance for mechanical design, ISO 13485,FDA 21CFR part 820,CE,UL ,DFMEA, PFMEA, DOE. Verification & Validation, DMR, DHF, TCF. Overall owner for the Mechanical design and project deliverables to customer. Hands on experience in system architecture, HLD's and LLD's.

Requirements:

−    Basic: B.E – Mechanical Engineering

−    Desired: M.E/ M.S – Mechanical Engineering

−    Domain: Medical – Mandatory.

Basic Requirement:

−    At least 10 years experience in Mechanical Design End to End Medical Device Product development projects a must.

−    An SME in mechanical design for medical devices. Experienced with Solid Works, PRO E, AutoCAD, Unigraphics and other standard design tools compulsory FEA,CFD, Structural, Thermal Analysis.

−    Good command of English

−    Result-oriented, team player, and able to work independently.

 

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