- Bachelor's degree
- Master's degree
- FDA regulations
- Electrical engineering
- Communication skills
- ISO 13485
Wondfo USA is currently seeking a Senior Mechnical Engineer to work on innovative point-of-care (POC) diagnostics product. An ideal candidate should have extensive hands-on experience designing, developing, and sustaining medical diagnostic instruments, preferably point-of-care (POC) devices. This individual will also be expected to work closely with the assay team to bring innovative molecular diagnostic products from feasibility to market.
Design, develop and prototype innovative POC molecular instrument and its submodules, in accordance with design requirements.
Evaluate, document, and implement potential design and process changes to improve product performance, manufacturability, safety, and cost
Procure components, supplies, and equipment to support development as well as vendor selection and assessment
Develop, implement and document assembly methods and jig. Coordinate with vendors to meet timeline and specification requirements
Transfer designs to final production through liaison with manufacturing engineers and external suppliers
Provide support to regulatory application.
Provide supervision and mentorship to junior ME staff
Perform other duties as assigned
Bachelor’s degree plus 10 years’ experience or Master’s degree plus 7 years’ experience in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biotechnology or related discipline
Must have working knowledge of 3D modeling software, preferably Solidworks
Hands-on design and testing experience in one of the following categories: optics, motion control, thermal etc.
Excellent interpersonal, verbal and written communication skills.
Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks.
Experience with nucleic acid-based technologies and sample preparation/nucleic acid extraction from difficult clinical sample matrices is a plus.
Founded in 1992, Wondfo is a global company specializing in rapid diagnostics with laboratories in San Diego, Chicago, and twelve overseas offices. Wondfo earned a wide range of certifications from FDA CE, FSC, ISO 9001:2008, and ISO 13485:2012 quality system certification. Wondfo's sales network covers more than 140 countries and regions, providing an exciting opportunity for the distribution of quality products. Wondfo strives to improve the quality of life and human health by developing and improving point of care in vitro diagnostic tests. At Wondfo USA's R&D site in San Diego, you will assist in designing and creating medical devices for the healthcare market. As a crucial part of a dynamic team, you will be involved in developing research ideas, executing experiments, and strategizing and developing these concepts into viable products.