Principal Mechanical Engineer

Roles and Responsibility

The candidate will be part of Company engineering team and reporting to R&D Director. The Principal Mechanical Engineer will contribute towards ME Engineering activities throughout the Product Development cycle of the company Products.

Duties and Responsibilities– Other duties may be assigned :

• Responsible to design fluid architectures for the therapy Devices
• Lead system level design and testing activities, closely working with system engineering team
• Perform mechanical engineering activities to develop new modules and systems from concept to production
• Perform engineering activities required for support of released products for product development, quality improvement, COGS reduction, and manufacturing issues resolution
• Work with other simulation / electronic / mechanical engineers at IN and SG to ensure product performance, reliability and cost expectations are met.
• Lead projects related to cost, quality, design, and productivity using methodology such as Tolerance Stack, Process Capability (Cpk), FMEA, Minitab, etc.
• Operate within a project team and assume responsibility to design, develop and verify new products from concept through to production
• Participate in the preparation and review of system documentation including System Specifications, Regression Analyses, Risk Analyses, Regulatory Submissions
• Testing, verification, and validation of products and alterations to ensure they meet the necessary requirements and specifications
• Identify gaps in design proposals, technical capabilities / techniques, and supports the development of strategies to overcome them through DFM & DFS practices.
• Conduct technical design reviews at system or subsystem levels in projects.
• Work within medical regulatory requirements (FDA, ISO, IEC)

Education and Experience :