Outset is a medical technology company pioneering a first-of-its-kind
technology to reduce the cost and complexity of dialysis. The Tablo
Hemodialysis System, FDA cleared for use from the hospital to the home,
represents a significant technological advancement that transforms the
dialysis experience for patients and operationally simplifies it for
providers. Tablo serves as a single enterprise solution that can be utilized
across the continuum of care, allowing dialysis to be delivered anytime,
anywhere and by anyone. The integration of water purification and on-demand
dialysate production enables Tablo to serve as a dialysis clinic on wheels,
with 2-way wireless data transmission and a proprietary data analytics
platform powering a new holistic approach to dialysis care.
As a member of the growing Reliability Engineering team within Product
Development, the Senior Reliability Engineer will take the lead in delivering
and demonstrating meaningful reliability on our products. This engineer will
be responsible for designing and executing internal and external reliability
tests (such as HALT, ALT, robustness testing, chemical compatibility testing,
shock/vibration, and more), and identifying failures through analysis of
field, vendor, and internal test data. Then, they will carry out
investigations as the technical lead, using industry best practices for root
cause identification and failure analysis. They will guide the teams to
implement a corrective action and demonstrate reliability improvement with
that correction. In general, this role will take on a holistic, end-to-end
approach to finding failures, identifying root causes, implementing
mitigations, and demonstrating reliability improvement.
- Be an ambassador for reliability engineering on cross-functional projects, ensuring we are always doing all that we should to ensure a reliable product for our customers.
- Promote a reliability-focused culture, pushing for reliability rigor at every stage of design and development.
Essential Job Functions and Responsibilities
- Utilize DfR best practices to meet our reliability goals and targets.
- Be the technical lead of root cause investigations of reliability failures that we identify:
- Generate top failures and kick off investigations as needed.
- Lead cross functional meetings to deep dive into issues and brainstorm next steps
- Use best practices and tools to confirm and reject root cause hypotheses (FMEA, fishbone, fault tree, DOE, etc).
- Recommend corrective actions and mobilize the team to implement the corrections.
- Through testing and/or field analysis, demonstrate reliability improvement of the implemented corrections.
- Work with the teams and leaders to create a Reliability Program Plan.
- Evaluate the strengths and weak points of the plan, and communicate these to leaders.
- Design, execute, and oversee reliability tests as needed by the program:
- Component, subsystem, and/or system level testing.
- Internal lab testing, testing at outside test houses, and/or testing at suppliers.
- Accelerated life testing, HALT, shock/vibration, chemical compatibility testing, robustness testing, reliability growth testing, etc.
- Evaluate test design constraints and trade-offs, and balance the tests accordingly.
- Fixture construction and automation where needed.
- Model failures and suspensions to assess reliability distributions and quantify reliability levels. Interpret these models to track towards our targets and recommend actions.
- Create and provide presentations to leaders on top issues and progress on ongoing tests and investigations.
- Help to educate other engineers and leaders on reliability engineering statistics and methodology.
- Maintain documentation of test protocols, procedures, and reports.
- Bachelor’s degree in Biomedical, Mechanical, Materials, or Reliability Engineering or equivalent
- Minimum of 5 years of experience in reliability engineering AND/OR engineering in product development with a focus on root cause investigation.
- Master’s degree preferred.
- CRE certification preferred.
- Knowledge and demonstrated use of reliability statistics (Weibull modelling, PDFs, CDFs, hazard rate functions, conditional reliability, confidence bounds, sample size determination, etc)
- Experience using reliability modelling software (Reliasoft, Minitab, and/or JMP)
- Experience designing and executing reliability tests (ALT, shock/vibe, HALT, etc)
- Experience overseeing external testing at suppliers.
- Experience leading technical root cause investigations.
- Experience working on cross functional product development teams.
- Experience providing clear and actionable presentations to leadership.
- Proficient with Excel and Powerpoint.
- Experience with Salesforce databases preferred.
- Must be an effective communicator.
- Must be able to work in a fast paced and dynamic environment.