Outsetmedical
Design Verification/Reliability Tester
San Jose, California. Posted 4 days ago
The role
The Design Verification/Reliability Tester will execute design verification, reliability, and feasibility testing on the Tablo Hemodialysis System and its consumables. This role involves recording test results under controlled protocols and maintaining lab equipment.
What you will do
- Perform design verification, reliability and feasibility testing on the Tablo Hemodialysis System under controlled test protocols.
- Collect and record the data as instructed in the test protocol, in accordance with Good Documentation Practices (GDP) and data-integrity requirements
- Document test deviations, anomalies, and failures accurately and completely, and escalate them to the responsible engineer in a timely manner
- Operate test and measurement equipment within its calibration period; identify and report out-of-calibration or malfunctioning equipment
- Maintain the lab and test systems in clean and operable condition
- Keep the lab stocked with consumables and materials required to perform the test
- Update validation and verification protocols with approval from R&D engineering
- Perform simulated treatments in the lab environment on the hemodialysis machine
- Track repairs on all machines and provide updates on repair status as needed
- Assist engineers in system troubleshooting and identifying technical solutions.
Required qualifications
- High School Diploma or equivalent
- 1+ years of relevant hands-on experience in testing, or an associates or higher degree in a technical discipline
- Extreme attention to detail and good documentation practices
- Ability to work effectively in a fast paced and dynamic environment
- Being on time and able to work on restricted schedules as well as weekends and extra time if needed
- Basic knowledge of Microsoft Word and Excel
Nice to have
- Strong written and verbal communication skills
- Associates or higher degree in electrical engineering or computer engineering
- Experience operating test equipment including oscilloscopes and multimeters
- Experience with medical devices or complex electro-mechanical / fluidic systems
About the company
Outset is a medical device company focused on creating technology to redefine the landscape of dialysis. Their Tablo Hemodialysis System is FDA cleared for use in hospitals, clinics, and homes.