Design Verification/Reliability Tester
Outset Medical
Summary
The Design Verification/Reliability Tester position is part of the Systems and Test Engineering group under the Technology and Product Development department. This is a hands-on role whose primary responsibility is to execute design verification (DV), reliability, and feasibility testing on the Tablo Hemodialysis System and its consumables under approved, controlled test protocols, and to record test results in accordance with Good Documentation Practices (GDP).
Job description
Position Overview
The Design Verification/Reliability Tester position is part of the Systems and Test Engineering group under the Technology and Product Development department. This is a hands-on role whose primary responsibility is to execute design verification (DV), reliability, and feasibility testing on the Tablo Hemodialysis System and its consumables under approved, controlled test protocols, and to record test results in accordance with Good Documentation Practices (GDP).
Essential Job Functions and Responsibilities
- 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.
- Follow company's safety and health guidelines and other related policies.
- Configure, adjust, and operate laboratory equipment.
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
Desired Qualifications
- 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
Requirements
- 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
- 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
Company overview
Outset Medical is a pioneering medical technology company headquartered in San Jose, California, focused on transforming the dialysis industry through innovative solutions. Founded in 2010, the company has developed the Tablo Hemodialysis System, a groundbreaking technology that significantly reduces the cost and complexity of dialysis treatment. Tablo represents a major technological advancement that has received FDA clearance for use across the continuum of care, from hospital settings to home environments. The system integrates water purification and on-demand dialysate production, effectively serving as a mobile dialysis clinic with wireless data transmission capabilities. Outset Medical's mission centers on revolutionizing one of healthcare's largest and most stagnant areas by delivering improved patient experiences while lowering costs for healthcare providers. With approximately 501-1,000 employees and operations across the United States, the company manufactures its products in North America and has raised significant funding, including a recent $169 million investment. Outset Medical is publicly traded on NASDAQ under the symbol OM and continues to drive widespread adoption of its transformative dialysis technology.