Openings

We are currently looking for Engineer & Junior Engineer in the following direction. The Engineer will work on our products and turn the prototypes into a commercial system. 

Responsibilities: 
Modifying the current prototype for production needs/ new features; 
Modifying the current prototype for regulatory compliance; 
Developing new features for the prototype while working with the clinical team; 
Communication with external parties like manufacturers and regulatory consultants; 
Undertaking other ad-hoc tasks and projects as assigned by the team 
The appointee(s) will work with the research team and clinical collaborators for further R&D of the technology and clinical trials. 

Requirements: 
• Bachelor’s/Master’s/Doctoral Degree in Mechanical Engineering or related disciplines (Fresh graduates are welcome); 
• Mechanical CAD(in SolidWorks) and prototyping experience (3D printing, laser cutting, CNC machining, etc.) with strong hands-on skills; 
• Experience in product realization, related industrial experience, the development of instrumentation, and/or regulatory compliance; 
• Knowledge of magnetics, optics, industrial design, QMS, and GMP will be advantageous; 
• Programming experience in MATLAB and LabVIEW is a plus but not required; 
• Ability to work in a fast-paced environment; 
• Willingness to learn and expend skill set to fill multiple Engineering roles; 
• Ability to communicate well with co-workers and external parties; 
• Ability to work independently without micromanagement 

Appointees with no aforementioned knowledge/experience will be considered as Junior Engineers.  

We are currently looking for Post-doc & Research Assistant in the direction of bridging micro-/ nanotechnology and functional material with robotics technology or MEMS at small scales. 

Responsibilities: 
• Development of new bio-sensing microrobot targeting different pathogens;
• Evaluation of the developed device & technology in wet lab with lab & patient sample (clinical trial);
• Performing tests and experiments on campus and clinical sites. He/ she will work collaboratively with other research staff and students in both the engineering team and the biological experiment team;
• Undertaking other ad-hoc tasks as assigned by the research team 

The appointee(s) will work with the research team and clinical collaborators for further R&D of the technology and clinical trials.

Requirements: 
• Bachelor’s, Master’s, or Doctoral Degree in Biomedical Science/ Biochemistry/ Biomedical Engineering/ Molecular Biotechnology/ Material Chemistry/ Physics/ Material Science/ Biology/ Microbiology or related disciplines;
• Experience in the development of biomedical, diagnostic/sensing agent/device/instrumentation, carbon dots, and/or related industrial experience will be advantageous;
• Good track record of high-quality research/projects; and
• Good communication skills and the ability to work independently. 

As our first dedicated Regulatory Affair Associate, you will play a pivotal hands-on role in building and executing our global regulatory strategy. 

Responsibilities:  
• Manage device classification, predicate selection, substantial equivalence argument, and labeling requirements. 
• Support clinical and performance evaluation strategy, including liaison with CROs and clinical investigators. 
• Prepare, compile, and submit regulatory dossiers 
• Lead the creation and maintenance of Technical Files, Design Dossiers, Risk Management Files, Clinical Evaluation Reports, and Post-Market Surveillance plans 
• Collaborate closely with R&D, Quality, and Clinical teams to ensure design control and risk management inputs are regulatory-compliant from the start. 

Requirements:  
• Bachelor’s degree in Life Science, Biotechnology, Engineering, or related disciplines. 
• Experience with regulator frameworks (FDA, NMPA, MDR, …) and documentation will be a big plus 
• Excellent organizational, communication, and coordination skills. 
• Manage multiple priorities in a deadline-driven environment without micromanagement 
• Team player with great interpersonal skills and a strong sense of ownership 

Our series of medical instruments is controlled and monitored through desktop applications. You will be the primary software owner within our engineering team. 

Responsibilities: 
• Develop the framework that could be used for our product lineup 
• Handle communication, automation logic with our instrument via USB or other means 
• UI/UX for users 
• Compliance with relevant regulatory standards 
• Deployment of the application 

Requirements: 
• Experience in production desktop applications 
• Knowledge of LabVIEW is advantageous 
• Modern software practices: Git, CI/CD, unit testing, static analysis, clean architecture 
• Ability to read schematics and debug low-level protocol issues with a logic analyzer or oscilloscope when needed is advantageous 
• Previous work on regulated software (medical device ideal; aerospace automotives, or fintech also valued) 
• Willingness to write the documentation regulators expect