Job: Senior/Staff Engineer

Senior/Staff Engineer

Location:

San Diego, CA

Job Information:

Job Title: Senior/Staff Engineer

Status: Regular Full Time

Benefits Eligible: Yes

Location: San Diego, CA

Job Description

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.

Responsibilities

  • 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

Other Requirements/Qualifications:

  • 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.