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Mechanical Engineer, Diagnostics Development Hub

2 weeks ago

Singapore A*STAR Agency for Science, Technology and Research Full time

Job Description

DxD Hub is a national platform dedicated to leading MedTech innovation through partnerships with a strong passion to create positive health outcomes. We bring together promising technologies and collaborate with our partners to ensure that their products are validated, registered, and successfully deployed.

We are seeking an enthusiastic and self-directed Mechanical Engineer to join our team. As a vital member of our team, you will be responsible for the design, prototyping, and testing of mechanical systems for medical devices. You will be given your own project objectives and control of how these are achieved.

Join our innovative team and make a positive impact on healthcare by creating cutting-edge medical devices that enhance patient care and well-being.

Roles and Responsibilities

Design and develop mechanical parts, assemblies, and sub-systems for medical equipment or devices, meeting customer requirements including performance, safety, and regulatory compliance.
Create detailed 2D and 3D models using computer-aided design (CAD) software such as Solidworks.
Selection and sourcing of engineering components, and liaising with purchasers, contractors, or suppliers.
Conduct verification and validation testing to ensure compliance with regulatory standards, product specifications, and performance requirements.
Participate and be involved in product development discussions including brainstorming, design review, root cause analysis discussion, milestone review, etc
Design and create technical documentation including design specifications, test protocols, and reports, in compliance with regulatory requirements such as ISO 13485.
Collaborating with cross-functional teams, including project managers, engineers, scientists, and personnel from quality and regulatory to achieve project objectives.

Key Requirements

Bachelor?s Degree in Mechatronics Engineering, Mechanical Engineering, Bioengineering, Biomedical Engineering, or related field.
Experience in mechanical design and development, including proficiency in CAD software (e.g., SolidWorks, AutoCAD) and knowledge of design for manufacturability (DFM) principles.
Strong analytical and problem-solving abilities to identify and resolve technical challenges through innovative ways, analyse data, and make informed engineering decisions.
Ability to conduct root cause analysis study, troubleshoot, and resolve mechanical issues that arise during the product development lifecycle.
Good understanding of testing and validation processes for mechanical systems, including test plan development, test execution, and documentation.
Knowledge of relevant regulatory standards and requirements, such as ISO 13485 and FDA regulations for medical devices will be an added advantage.
Excellent teamwork and communication skills to effectively collaborate with cross-functional teams, stakeholders, and external partners.

**Type of Employment**: Full-Time

**Work Location**: 3 Cleantech Loop