The Product Development Engineer will join a fast-growing team of chemists, biochemists, and engineers to develop novel point of care tests (POCT) and rapid diagnostic solutions for priority infectious diseases with unmet clinical needs. The ideal candidate as a product design and development engineer will assist the product development and commercialization of several innovative diagnostic platforms established and centered on using isothermal amplification or Lab-on-Chip technologies.
Duties and Responsibilities
- Perform research to identify emerging trends and technologies for point of care tests (POCT) of infectious diseases.
- Interact with the Diagnostic Team (Dx Team) to research, design, prototype, evaluate and develop devices for processing and testing clinical samples.
- Test and validate established diagnostic assays on the device prototypes and make modification and improvement to meet target product profile and intended end use.
- Plan and conduct product manufacturing with external OEMs.
- Maintain detailed design history files.
Required Key Competencies
- Master or PhD degree in Engineering, Analytical Chemistry or equivalent with substantial design experience in R&D environment for POCT devices.
- Demonstrate superior mechanical design skills, proficient in CAD modeling and rapid prototyping.
- Have knowledge and experience in 3D printing, microfabrication or injection molding (a plus).
- Have a track record for R&D experience of biomedical devices.
- Be familiar with the medical device design control and development process.
- Experience with device automation is a plus.
- Be able to plan and execute assigned projects to achieve the overall project goals and specific analytical objectives.
- Be able to work independently and communicate efficiently both internally in the team and externally with collaborators and manufactures.
- Maintain high attention to detail, demonstrate strong creativity and problem-solving skills to address technical issues and improve product performance.