Senior Reliability Engineer

Outset Medical, Inc.•San Jose, CA

47d

About The Position

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.

Requirements

Bachelor's degree in Biomedical, Mechanical, Materials, or Reliability Engineering
Prefer a minimum of 7 years of experience in reliability engineering AND/OR engineering in product development with a focus on root cause investigation.

Nice To Haves

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.

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.