Eko Health, Inc seeks a Manager of Hardware Quality at its facility located at 2100 Powell St, Suite 300, Emeryville, CA 94608. Responsible for the implementation and improvement of Eko’s Design Assurance program for Hardware products. Oversee DA activities in regard to the development of both new product and product improvements from initial concept, product development, verification planning & testing to product implementation Authors, edits, organizes, maintains, and reviews Design History Files (DHF) for new and existing products. Responsible for the implementation and maintenance of an ISO 14971 compliant risk management process. Responsible for Supplier Quality management including evaluation, qualification, and monitoring. Manage all activities related to Supplier Quality Engineering in accordance with policy, including supplier selection and evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments, supplier performance reviews and supplier development. Manage team members responsible for supplier quality and external consultants. Compile with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Audit, identify and support implementation of Design process improvements. Assist in preparation of global regulatory submissions, documentation, technical files, etc. Interface with regulatory bodies (FDA, State FDB, and Notified Body) during external audits of the quality system as needed. Oversee the company’s change management processes. Assist technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation as required. Hybrid Schedule (minimum 1 office day/week).
REQS: Bachelor’s degree, or foreign equivalent, in Electrical Engineering, Mechanical Engineering, Manufacturing, Quality Assurance or a related field plus 5 years of experience as a Quality Assurance Engineer or related occupation. Alternatively, Master’s degree, or foreign equivalent, in Electrical Engineering, Mechanical Engineering, Manufacturing, Quality Assurance or a related field plus 3 years of experience as a Quality Assurance Engineer or related occupation.
Additionally, the applicant must have employment experience with
Implementation of medical device design control and risk management methodologies compliant to ISO14971:2019;
Experience with cross-functional supporting a medical device Research and Development team as a Quality Assurance member;
Implementation of medical device State-of-the-art design standards, such as IEC 60601-1, ISO 62366-1;
Medical Device Quality Management System requirements pursuant to international regulations, such as US FDA 21CFR820, EU-MDD/MDR, ISO13485:2016;
Experience with managing medical device(s) throughout their respective product lifecycles.
Benefits and Perks We Offer:- Eko was recognized by “Great Place to Work” in 2020 and 2021
- Paid-time off
- Medical/Dental/Vision, Disability + Life Insurance
- Volunteer time off
- One Medical membership
- Parental Leave
- 401k Matching
- Work from home equipment stipend
- Flexible schedules
- Wellness programs (Wellness Wednesdays, Time off)
- Wellness perks (Headspace, Ginger, Aaptiv, Physera)
- Learning and Development stipend
$211,058 - $216,000 a year
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.
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.
