Senior Quality Engineer

Tesseract Health

Tesseract Health

Quality Assurance
Guilford, CT, USA
Posted on Tuesday, August 15, 2023

Who We Are

identifeye HEALTH's mission is to democratize healthcare delivery to everyone on a global scale. We are reinventing medical devices to leverage the health information in the human eye and championing a new era of healthcare by creating portable, affordable, easy to use, connected devices for early disease detection and monitoring. identifeye HEALTH is well-funded and recently raised a series B round of $80M.

We are part of 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. Our 4Catalyzer sister companies include Butterfly Network, the first whole-body Ultrasound-on-ChipTM, and Hyperfine, the first FDA-cleared portable point of care MRI. We are fostering a culture of technical excellence and positive teamwork to solve real-world problems that help improve healthcare for billions of people around the world.

Joining identifeye HEALTH is the opportunity to redesign the future of healthcare through the power of technology. Join us on this journey to maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

  • Prioritize the Patient - We make products that remove barriers between quality care and the people who need it
  • Data-Driven Decisions - We search for the best solutions; objective, backed by data, and optimized for speed, simplicity and scale
  • Support Each Other - We celebrate the ideas and contributions of our teammates and recognize that we can only succeed as a team, and when each person feels heard and valued
  • Simplify - We build intuitive solutions to simplify patient care

What You Will Be Doing

The Senior Quality Engineer will play a key role in the design, development, and production of high quality and compliant medical devices at identifeye, as well as the maintenance and improvement of an effective Quality Management System.

As part of our team, your core responsibilities will be to:

  • 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

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

  • 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%.

Preferred Qualifications

  • ASQ, CQE, CQA, or ISO 13485 Auditor certifications
  • Experience with 510(k) or PMA submissions
  • Experience with Jira or other similar requirements management software
  • Experience with Omnify, Agile, or similar Product Lifecycle Management software

What We Offer

Anticipated Salary Range: $120,000 to $150,000 annually. The base salary range represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range based on various factors including but not limited to work location, operational needs, potential employee qualifications and other considerations permitted by law. The range listed is just one component of our total compensation package for employees. Other rewards may include annual bonuses, equity and program-specific awards. In addition, we provide a variety of other benefits to employees including but not limited to:
  • Fully covered medical insurance plan, and dental & vision coverage. As a health-tech company, we place great worth on our team’s well-being.
  • 401(k) plan. Everyone should be encouraged to save for their retirement adventures!
  • Flexible PTO policy and remote/hybrid work arrangements. We believe in taking personal responsibility for managing our own time, workload and results.
  • Free onsite meals & kitchen stocked with snacks at our Guilford, CT campus.
  • Annual "Improve Your Work Environment" stipend. We support what you need to be your best self when at work!
  • Professional development reimbursement. Let's grow together!
  • More exciting employee perks... but most importantly, the opportunity to build a revolutionary healthcare product and save millions of lives!

For this role, we provide visa assistance for qualified candidates.

identifeye HEALTH Inc. does not accept agency resumes.

identifeye HEALTH Inc. is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.