Senior Reliability Engineer at Outset Medical | Powderkeg

Company Overview

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.

Position Overview

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.

Required Qualifications

  • 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.

Desired Qualifications

  • 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.
Job Summary
  • Job Title
    Senior Reliability Engineer
  • Company
    Outset Medical
  • Location
    San Jose, CA
  • Employment Type
    Full time
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