Job Description
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:
Bachelor degree or above in Mechanical Engineering 7+ years’ in medical devices and Mechanical Engineering experience Required to have experience in at least 2 complete product lifecycles i.e. from product conceptualization to design, development and manufacturing of medical devices Electro-mechanical integration and exposure Solid understanding of general manufacturing process like injection molding, sheet metal fabrication, machining with knowledge in tool engineering and design Familiar with prototyping techniques and tooling DFM, 3D modelling with Creo/Solidworks Familiar with preparing 2D drawings with GD&T. Able to perform tolerance analysis. Familiar with fluid dynamics, CFD analysis Proactive attitude with a strong passion for product commercialization. Team Player, Strategic with go-getter attitude Ability to negotiate and sustain networking relationships Strong interpersonal, motivating and influencing skills for interacting with team members, business partners, suppliers and management. Good Project Management Skills Ability to adopt Risk based project execution
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