We are seeking an R&D Mechanical Engineer who will play a vital role in developing cutting-edge medical monitors that have the potential to save lives worldwide. In this position, you will have the opportunity to contribute throughout the entire life-cycle of the devices, including architecture, design, development, and sustaining engineering for both existing and new products. We are looking for a candidate who possesses hands-on technical expertise and a solid understanding of modern development methods to ensure timely product launches without compromising quality or requirements. As the chosen candidate, you will be responsible for leading mechanical aspects across the product life-cycle.

Responsibilities:

Lead the development of complex and innovative mechanical subsystems for a new medical device.
Design various mechanical aspects of the product, including specifications, injection molded parts, electro-mechanical interfaces, usability aspects, and industrial design interface.
Collaborate with internal teams such as industrial designers, software and hardware engineers, and interface with external teams in product, engineering, service, and marketing.
Write and review R&D documentation, including test protocols, analysis of test results, and report generation.
Coordinate with external vendors for component selection, manufacturing, and assembly.
Provide solutions that optimize performance, serviceability, manufacturability, and cost.
Perform necessary analysis, testing, troubleshooting, and documentation.

Qualifications:

Minimum of 5 years of experience in mechanical engineering as part of an R&D team.
Strong proficiency in CAD, with experience in SolidWorks considered an advantage.
Must have knowledge of the ASME Y14.5 standard.
Experience with plastic injection molding, sheet metal, CNC, and additive manufacturing.
Familiarity with the PCBA development process is a plus.
Experience working with overseas suppliers is advantageous.
Knowledge of preparing regulatory submissions to CE and FDA is a plus.
Self-motivated with a strong ability to learn quickly and work independently as well as in a team.
Fluent in English, both written and verbal communication skills.
Bachelor’s Degree in Mechanical Engineering.