Senior Quality Engineer
Confirmed live in the last 24 hours
 identifeye HEALTH

11-50 employees

Non-invasive health diagnostics through eye examination
Company Overview
are Identifeye Health, a company that is pioneering a non-invasive diagnostic platform that leverages the unique visibility of the retina to detect a wide range of health conditions. Our commitment to democratizing healthcare is evident in our efforts to provide affordable, convenient, and efficient access to healthcare, enabling patients to be more involved in their care decisions. Backed by the 4Catalyzer accelerator, we are part of a robust network of scientists and engineers, and our founder, Jonathan Rothberg, is renowned for his significant contributions to DNA sequencing and ultrasound technology.
Data & Analytics
Hardware

Company Stage

Series B

Total Funding

$80M

Founded

2018

Headquarters

Guilford, Connecticut

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

-4%

2 year growth

2%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
CategoriesNew
Medical, Clinical & Veterinary
Diagnostics & Laboratory Professionals
Healthcare Administration & Support
Requirements
  • Bachelor’s Degree, preferably in engineering or other STEM-related field
  • At least 5 years of hands-on quality or regulatory experience in a U.S. FDA and ISO 13485 regulated environment
  • Experience with ISO 14971 and IEC 62304
  • Proven experience as quality representative on cross-functional teams
  • Ability to work onsite in Guilford, CT or Redwood City, CA is preferred. Otherwise open to remote work arrangements. If remote, must have the ability to travel up to 20%.
Responsibilities
  • Serve as quality representative on new product development projects, providing guidance to product managers and other team members in defining and documenting projects in compliance with our Quality Management System
  • Support the establishment, maintenance, and continuous improvement of the identifeye Quality Management System
  • Lead product risk management, including hazard identification, risk evaluation, and risk control within product teams
  • Work with identifeye's software team to ensure the Software Development Life Cycle is compliant, efficient, and effective
  • Serve as quality representative during design transfer, including onboarding of suppliers
  • Assist with other quality activities to help maintain the effectiveness of the Quality Management System