Principal Mechanical Engineer
2 weeks ago
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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