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Manufacturing Engineer

Company: Eko
Location: oakland
Posted on: May 3, 2021

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 ResponsibilitiesWrite work instructions for manufacturing processesMaintain Statistical Process Control (SPC) of key processesCommunicate between Manufacturing and Engineering Staff/DepartmentsOversee Manufacturing Process Data Collection Directs manufacturing team on data collection methodsEnsures Raw Material and Finished Product Specifications are written and updated Train Dedicated Maintenance TechniciansCreate Manufacturing Process test protocols (IQ, OQ, PQ) Write Process Flow Charts Maintain the Equipment Traceability ProcessMachine down time metrics available with countermeasures for improvementDefined/Documented Manufacturing Process RangesWrite user manuals for custom equipmentQualificationsBachelors' or Masters degree in Bioengineering, Electrical Engineering, Mechanical Engineering or related technical discipline3+ years of experience in mid/high volume manufacturing of electronic devicesExcellent written and verbal communication skillsAbility to be innovative, resourceful, and work with minimal directionExcellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teamsNice to HavesExperienced in ISO 13485 medical device developmentExperience in physiological sensing applicationsExperience in audio productsUnderstanding of FDA, GMP, and ISO guidelinesAbility to travel 10% of the timeEko 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.

Keywords: Eko, Oakland , Manufacturing Engineer, Other , oakland, California

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