Full-Time

Sr. Quality Engineer

Confirmed live in the last 24 hours

Outset Medical

Outset Medical

501-1,000 employees

Dialysis treatment and training solutions

Biotechnology
Healthcare

Compensation Overview

$135k - $183kAnnually

Mid

San Jose, CA, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in Electrical or Mechanical Engineering (or similar) required.
  • Minimum of 4+ years of hands on experience with quality engineering manufacturing and field support.
  • Prior experiences in a regulated environment, preferably medical device.
  • Familiarity with use of mechanical and electrical test equipment.
  • Basic statistical analysis skills and proficiency with MS Office.
  • Ability to work effectively in a fast paced and dynamic environment.
  • Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
  • Strong written and verbal communication skills.
Responsibilities
  • Investigate causes of quality problems identified from field complaints, field service records, manufacturing, final QC inspection, incoming inspection, and suppliers.
  • Manage the root cause analysis and corrective actions process of supplier quality issues.
  • Support departmental effort in CAPA investigation and completion.
  • Collect, analyze, trend, and communicate quality data throughout the organization.
  • Identify validation and/or verification required for design changes.
  • Support manufacturing, new product development, and regulatory to ensure compliance with all internal and external requirements; represent quality interests and concerns on project teams.
  • Implement and qualify software tools related to product or process changes.
  • Identify product quality and quality system improvement opportunities and drive procedure updates when required.
  • Carry out supplier qualification or surveillance audits, with supplier support and supplier advanced product quality planning. Write associated audit reports for distribution to senior management.
  • Support new product launches and/or manufacturing transfers and/or sourcing projects to ensure suppliers can deliver to the required quality standards.

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.

Company Stage

IPO

Total Funding

$378.4M

Headquarters

San Jose, California

Founded

2010

Growth & Insights
Headcount

6 month growth

-9%

1 year growth

-14%

2 year growth

-6%
Simplify Jobs

Simplify's Take

What believers are saying

  • FDA clearance of TabloCart with prefiltration boosts product flexibility and market share.
  • Partnership with U.S. Renal Care aligns with growing demand for home dialysis solutions.
  • $125M Series E funding enables R&D investment and market expansion.

What critics are saying

  • Multiple class action lawsuits could harm Outset Medical's financial and reputational standing.
  • Regulatory challenges, like the TabloCart shipment pause, may disrupt supply chains.
  • Dependence on partnerships may increase vulnerability to external market shifts.

What makes Outset Medical unique

  • Outset Medical's Tablo system integrates seamlessly with EMR platforms for efficient data management.
  • The Vascular Access Program enhances staff expertise in cannulation and vascular access management.
  • Their Bridge Program supports facilities transitioning to in-house dialysis services with expert staffing.

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Benefits

Medical, dental, & vision

Life Insurance/AD&D

FSA & HSA

401k

Parental leave

Pet insurance

Tuition reimbursement

PTO

Company events