May 19, 2021

Manufacturing Engineer

  • Eko
Full time Manufacturing

Job Description

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 Hayward. Duties and Responsibilities Write work instructions for manufacturing processes Maintain Statistical Process Control (SPC) of key processes Communicate between Manufacturing and Engineering Staff/Departments Oversee Manufacturing Process Data Collection Directs manufacturing team on data collection methods Ensures Raw Material and Finished Product Specifications are written and updated Train Dedicated Maintenance Technicians Create Manufacturing Process test protocols (IQ, OQ, PQ) Write Process Flow Charts Maintain the Equipment Traceability Process Machine down time metrics available with countermeasures for improvement Defined/Documented Manufacturing Process Ranges Write user manuals for custom equipment Qualifications Bachelors’ or Masters degree in Bioengineering, Electrical Engineering, Mechanical Engineering or related technical discipline 3+ years of experience in mid/high volume manufacturing of electronic devices Excellent written and verbal communication skills Ability to be innovative, resourceful, and work with minimal direction Excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams Nice to Haves Experienced in ISO 13485 medical device development Experience in physiological sensing applications Experience in audio products Understanding of FDA, GMP, and ISO guidelines Ability to travel 10% of the time Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through telehealth. The company is headquartered in Oakland, California and privately-held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others. 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.

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