Senior Reliability Engineer

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

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 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
• Master’s degree preferred.
• Prefer a minimum of 7 years of experience in reliability engineering AND/OR engineering in product development with a focus on root cause investigation.

Desired Qualifications

• 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.

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. 

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. 

Privacy is important to us. Please review our Applicant Privacy Notice. 

Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at peopleops@outsetmedical.com.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT 

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.