About Access Bio:
Access Bio is dedicated to the early detection and diagnosis of infectious diseases through its research, development, and manufacturing of in vitro rapid diagnostic tests, biosensors, and molecular diagnostic products. In 2020, we obtained Emergency Use Authorization for COVID-19 diagnostic products from the U.S. FDA, and are contributing to improving public health by providing COVID-19 diagnostic solutions across the United States.
Title: Quantitative Analyst
Division: Research and Development
Reports to: R&D General Manager
Quantitative medical device development including hardware and algorithm development.
Duties & Responsibilities
- Development of algorithms through signal analysis for quantitative medical devices
- Conversion analogue signals to digital signals
- Data statistical processing of digital signal
- Oversight of outsourced developers who develop SW and HW
- Reviewing design products that outsourced developers develop and suggesting problem solving and improvement
- Development and set up of QC methods for quantitative medical devices
- Documentation work related to SW and HW in DHF/DMR
Qualifications
- Minimum bachelor’s degree in a scientific and engineering discipline
- 10+ years' experience in IVD development
- Experience in quantitative medical device development and mass production transfer
- Experience in analyzing algorithms through signal analysis
- Experience in developing and setting up QC methods to compensate for signal differences between instruments
- Working knowledge of MS office (especially Excel) and database system.
- Firmware coding(Python, Java, or C++)
- Proficient in data statistical processing
- Proficient in documentation such as DMR/DHF
- Good communication and teamwork skills
- Able to follow instructions and strictly follow procedures.
Preferable Qualifications
- Master's or doctoral degree recipient
- Computer/Systems Engineering
- Statistics/Biology/Medical Engineering/ Chemistry
- English and Korean bilingual preferred
Job Type: Full-time
Pay: From $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
Work setting:
- In-person
Application Question(s):
- Minimum required salary?
- Do you need sponsorship now or in the future?
- How many years of experience in developing and setting up QC methods to compensate for signal differences between instruments?
- Do you have 10+ years' experience in IVD development?
- How many years of Firmware coding(Python, Java, or C++) experience?
- How many years of data statistical processing experience?
- How many years of quantitative medical device development including hardware and algorithm development?
- Are you authorized to work in the United States without restriction?
Education:
- Bachelor's (Required)
Language:
- , read and write Korean and English (Preferred)
Work Location: In person