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Project Engineer - Medical Device IV
Ref No.: 18-11159
Location: Concord, California
Start Date / End Date: 10/01/2018 to 03/31/2019
Duration:0-6 month(s)

Description/Comment:Must have experience in the medical device field with process development, test methods development, protocal and report writing, design verification and experience presenting technical concepts. EDUCATION: minimum of a bachelor's degree is biology or chemical engineering

Additional Job Details:Summary This position will have the primary responsibility for delivering and executing a design history file remediation plan for electromechanical medical equipment. In partnership with cross-functional team members, the position will ensure that a mature product line meets current regulations and best practices for medical electrical equipment, disposables (i.e. accessories) and reusable goods. A successful outcome guarantees the product will continue to serve patients with the high level of quality and reliability they expect from the brand. Responsibilities • Comprehend existing Design History File documentation, including Design Input, Design Output and Post-Market activities • Understand Electromechanical systems along with firmware to ensure there are no gaps in V&V plans and DHF, create and execute new protocols if needed. • Using gaps identified in a comprehensive Design History File audit, clarify and identify a succinct plan for closing gaps and prioritize work required to do the same • Demonstrate proficiency in medical device regulation(s), standards and current best practices as they apply to reusable medical electrical equipment • Remediate, in collaboration with a cross-functional team, the design history file, including product requirements, design specifications, component drawings and design traceability • Under minimal direction, prepare updates to system specifications, design documentation, test descriptions, hazard analysis, validation test procedures, and related documentation supporting software, hardware and product development to known standards • Define, write and execute engineering test protocols, analyze data and create summative test reports • Demonstrate proficiency in Human Factors Engineering and IEC 62366 for Usability Engineering; elaborate on use-related errors, user-based risk management and create usability engineering file • Must have experience in the medical device field with requirements development, test methods, protocol and report writing, design verification and experience presenting technical concepts to different levels within the organization. Requirements: Minimum 5 years' experience in medical device product development and/or sustaining activities Bachelor's degree; science or engineering degree preferred Experience with software development lifecycle in a regulated environment highly desireable