Senior Reliability Engineer at Outset Medical

San Jose, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, DialysisIndustries

Requirements

Expertise in DfR (Design for Reliability) best practices to meet reliability goals and targets
Ability to serve as technical lead for root cause investigations of reliability failures, including generating top failures, leading cross-functional meetings, using tools like FMEA, fishbone, fault tree, DOE, recommending corrective actions, and demonstrating improvements
Capability to work with teams and leaders to create, evaluate, and communicate a Reliability Program Plan, including assessing strengths and weak points
Proficiency in designing, executing, and overseeing reliability tests (e.g., component/subsystem/system level, internal lab, external test houses, suppliers; accelerated life testing, HALT, shock/vibration, chemical compatibility, robustness, reliability growth testing), including evaluating constraints/trade-offs, fixture construction, and automation
Skills in modeling failures and suspensions to assess reliability distributions, quantify levels, interpret models, track targets, and recommend actions
Ability to create and deliver presentations to leaders on top issues, test/investigation progress
Experience educating engineers and leaders on reliability engineering statistics and methodology
Holistic end-to-end approach to finding failures, root cause analysis, mitigations, and demonstrating reliability improvements
Ability to act as an ambassador for reliability engineering on cross-functional projects and promote a reliability-focused culture

Responsibilities

Utilize DfR best practices to meet reliability goals and targets
Lead root cause investigations: generate top failures, kick off investigations, lead cross-functional meetings for deep dives and brainstorming, use best practices/tools (FMEA, fishbone, fault tree, DOE) to confirm/reject hypotheses, recommend and mobilize corrective actions, demonstrate improvements via testing/field analysis
Collaborate with teams/leaders to create a Reliability Program Plan, evaluate strengths/weak points, and communicate to leaders
Design, execute, and oversee reliability tests as needed (component/subsystem/system level; internal/external/supplier testing; HALT, ALT, shock/vibration, chemical compatibility, robustness, reliability growth, etc.), balance test constraints/trade-offs, construct/automate fixtures
Model failures and suspensions to assess reliability distributions, quantify levels, interpret to track targets, and recommend actions
Create and provide presentations to leaders on top issues and progress on tests/investigations
Educate other engineers and leaders on reliability engineering statistics and methodology
Design and execute internal/external reliability tests (HALT, ALT, robustness, chemical compatibility, shock/vibration, etc.)
Identify failures through analysis of field, vendor, and internal test data
Guide teams to implement corrective actions and demonstrate reliability improvements
Serve as ambassador for reliability on cross-functional projects and promote reliability-focused culture throughout design/development

Skills

Reliability Engineering

HALT

ALT

Robustness Testing

Chemical Compatibility Testing

Shock Testing

Vibration Testing

Root Cause Analysis

Failure Analysis

Corrective Actions

Outset Medical

Dialysis treatment solutions and training programs

About Outset Medical

Outset Medical focuses on improving dialysis treatment in the healthcare sector. Their main product, Tablo, is a system that simplifies the dialysis process by integrating with electronic medical record (EMR) platforms, allowing for better management of patient data with real-time updates and alerts. This helps streamline workflows from charting to billing. In addition to Tablo, Outset Medical provides educational programs and hands-on training for dialysis professionals, including a Vascular Access Program that enhances staff skills in cannulation and vascular access management. They also offer a Bridge Program to assist facilities transitioning to in-house dialysis services by providing experienced dialysis nurses for training and support. Outset Medical aims to enhance the quality of care for dialysis patients across various settings, including hospitals, outpatient clinics, and home care.

San Jose, CaliforniaHeadquarters

2010Year Founded

$542.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Medical, dental, & vision

Life Insurance/AD&D

FSA & HSA

401k

Parental leave

Pet insurance

Tuition reimbursement

PTO

Company events

Risks

Multiple class action lawsuits could lead to financial and reputational damage for Outset.

The shipment pause of TabloCart with Prefiltration may have disrupted supply chains.

Reliance on partnerships, like with U.S. Renal Care, poses risks if expectations aren't met.

Differentiation

Outset Medical's Tablo system integrates with EMR platforms for streamlined dialysis workflows.

The company offers a Vascular Access Program to enhance staff expertise in cannulation.

Outset Medical provides a Bridge Program for facilities transitioning to in-house dialysis services.

Upsides

Increased adoption of home dialysis solutions aligns with Outset's partnership with U.S. Renal Care.

The demand for portable dialysis machines supports the market potential for Outset's Tablo system.

Outset's FIPS 140-3 validation enhances cybersecurity, aligning with new medical device standards.

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