Senior Software Quality Engineer

Quality Assurance San Francisco, California


Description

Spire Health is building the future of remote patient monitoring. We give physicians insights into their patients' health between doctor visits, helping them better manage high-risk chronic disease patients. In particular, we serve patients in the U.S. who have chronic respiratory diseases (COPD, Asthma) with a novel sensor and algorithm system that identifies changes in a patient's health. We focus our efforts on patients identified by their doctor as good candidates for our monitoring program and enroll them at little to no cost to the patient.

Responsibilities:

  • Support the SW Development effort to be compliant to IEC62304 and Design Control
  • Perform SW V&V including writing up the protocols and reports. Perform V&V test execution
  • Develop Automated testing for product SW V&V to be used especially during Regression testing
  • Perform Other than Product SW validation, which includes QMS SW, Manufacturing Testing SW.
  • Participate in all Product SW Development Design Review, including Code Review
  • Ensure that the Product SW launched will have minimum number of acceptable bugs
  • Lead the Risk Management effort for SW Risk Management development that includes SW Risk 
    Analysis per ISO14971, and SW-FMEA as appropriate
  • Perform Full System V&V focusing on the SW performance on the Product SW


Qualifications:

  • 5+ years in Medical Device SW Enviroments
  • 3+ years as SW Quality Engineer 
  • Previos experience as a SW/FW Developer 
  • Proficient in IEC62304 and ISO14971
  • Profecient in CSV (Computerized System Validation)
  • SW Development following Design Control per QSR 820.30