Sahil Vasani

Hardware Quality Manager @Eko Health

Emeryville, CA, US

Responsible for the implementation and improvement of Eko’s Design Assurance (DA) program for Hardware (Electromechanical) products. Oversee DA activities in regards to the development of both new product and product improvements from initial concept, product development, verification planning & testing to product implementation. Responsible for the implementation and maintenance of an ISO 14971 compliant risk management process for hardware and software medical devices including artificial intelligence (AI) incorporating medical devices. Responsible for Supplier Quality management including evaluation, qualification, and monitoring. Manage all activities related to Supplier Quality Engineering in accordance to 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. 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. Oversees 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.

St. Vincent college of engineering and technology

Bachelor’s Degree, Mechanical Engineering, 3.50

Wayne State University

Master’s Degree, Mechanical Engineering, 3.50