Full-Time

Senior Software Quality Assurance Engineer

Posted on 5/3/2024

Element Science

Element Science

51-200 employees

Develops wearable cardioverter defibrillators

Data & Analytics
Hardware

Senior

San Carlos, CA, USA

Required Skills
Software Testing
Requirements
  • Bachelor’s degree in Software, Electrical Engineering, or Computer Science
  • 7+ years of recent medical device experience
  • Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices
  • Experience in Threat Modeling and Software Risks
  • Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1
Responsibilities
  • Author validation plans, protocols, software risk analyses for a medical device
  • Execute validation testing based on product requirements
  • Create, review and approve reports for V&V software testing and test scripts
  • Collaborate with firmware and software R&D engineers on improvements or new products
  • Provide guidance to Threat Modeling for cybersecurity
  • Coach and mentor junior team members on current best practices
  • Lead and participate in project teams assigned to new products
  • Support and investigate customers complaints related to product software
  • Involved in monitoring software anomalies

Element Science is at the forefront of medical technology with its development of the Jewel Patch Wearable Cardioverter Defibrillator, a device designed to treat life-threatening heart rhythms. This commitment to creating cutting-edge, life-saving technology not only reflects an innovative approach to tackling cardiac conditions but also demonstrates a deep commitment to improving patient outcomes. Working here means being part of a dedicated team that's shaping the future of heart disease treatment, backed by advanced detection technologies and a focus on significant health challenges.

Company Stage

Series C

Total Funding

$183.1M

Headquarters

San Francisco, California

Founded

2013

Growth & Insights
Headcount

6 month growth

6%

1 year growth

12%

2 year growth

62%
INACTIVE