May 19, 2021
Eko is a venture-backed digital health company which harnesses the power of smartphones and cloud data for screening and monitoring individuals with cardiovascular diseases. We have built a platform of non-invasive cardiovascular monitoring devices, clinical software, and point-of-care decision support software to improve the delivery of cardiovascular care.
In 2015, we launched the Eko Core Digital Stethoscope, the first FDA-cleared digital stethoscope on the market to wirelessly stream heart and lung sounds to HIPAA-compliant software. It is now used by clinicians at over 1000 hospitals & health systems around the globe and was recognized as a “Best Invention of the Year” by TIME Magazine. Eko's latest FDA-cleared device, DUO, is the first combined digital stethoscope and ECG cardiac monitor with cardiac AI for in-clinic and at-home monitoring, offering 28 million heart disease patients the ability to seamlessly send cardiac data to their physicians.
Eko was established in 2013 and has offices in Oakland and San Francisco.
As a Hardware Quality Engineer at Eko, you will:
Ensure Quality Policy and Manual is up to date and being followed
Investigate and troubleshoot product or production issues.
Assist corrective actions, solutions, and improvements.
Inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
Collaborate with hardware engineering to test hardware products
Follow workflows, processes, and products comply with safety and regulatory regulations
Review and audit Batch History Records and test sheets for completeness, accuracy & compliance to GMP
Ensure Change Management Process is being followed (including customer notification)
Ensure Supplier Performance Monitoring and Feedback Process
Create certificate of conformance (responsible for conformance)
Ensure that products are designed with compliance in mind (Material requirements, battery creepage, ECG voltage scale...)
FMEA created linking all component specifications to product outcome (severity and effect)
Bachelor’s of Science degree or higher in Engineering.
2-3 years of experience in quality engineering, quality assurance, or a similar role.
Strong analytical and problem-solving skills
Excellent verbal and written communication skills
Excellent project management skills.
Nice to Haves:
Experience coding and using QA software tools and processes
Experience in physiological sensing applications
Eko is proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives. We celebrate diversity and are committed to building a diverse and inclusive team.