Job Title: Senior/Staff Engineer
Status: Regular Full Time
Benefits Eligible: Yes
Location: San Diego, CA
Wondfo USA is currently seeking a Senior Engineer to fill the exciting position in our expanding Research & Development branch. This individual must have extensive experience in designing, developing, and optimizing point-of-care (POC) diagnostic systems in an industrial setting, and will be collaborating with the R&D team from feasibility toward pre-market approval process of innovative molecular diagnostic products. Strong written and verbal communication skills is a must, as this individual will also interact closely with cross-disciplinary teams, including sales and marketing, scientists, other engineers, and the production team.
- Lead product design and development effort of reliable and cost-effective point-of-care medical devices and consumables, including prototype design, feasibility study, optimization, integration and testing of biological samples
- Apply fundamental knowledge and good laboratory practice to developing assays with the end goal of launching products
- Provide direction and mentor junior engineers and collaborate with assay development scientists in areas of expertise
- Drive evaluation and qualification of critical partners for product development and manufacturing
- Define specifications, critical parameters, test plans, statistical process control (SPC) metrics and QC approaches
- Demonstrated ability to communicate effectively both orally and in writing with colleagues throughout all levels of the organization
- Bachelor’s degree in Engineering or other related subjects with 7-10 years of relevant work experience or Master’s degree in Engineering or other related subjects with 5-8 years of relevant work experience in industrial setting.
- Read and interpret engineering specifications, drawings, schematics, and manufacturing instructions.
- Good data analysis skills (JMP, Minitab, Excel VBA).
- Design experience with injection molded parts, sheet metal, microfluidics, and motion control.
- Working knowledge of geometric dimensioning and tolerancing.
- Proficiency in Solidworks or other engineering software is required.
- Ability to work independently in a fast-paced and collaborative multidisciplinary setting, while contributing to a supportive and positive work environment.
- Experience with nucleic acid based technologies and sample preparation/nucleic acid extraction from difficult clinical sample matrices is highly desired.
- Experience with design control，pre-market approval process of medical device, such as 510(k) is preferred.
- Ability to travel 15%.
- Professional proficiency in Mandarin is a plus.
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.