Sr. Engineer – Design Quality Assurance

The Senior Design Quality Assurance Engineer is responsible for providing Design Quality leadership for new product development (NPD / NPI) of a Next-Generation (Gen2) medical device. In this role, you will partner directly with R&D, Clinical, Regulatory, and Operations to set quality direction, mentor engineering teams, and drive compliant, timely execution from concept to product release. Job Description: • Drive the design & execution of Production Release Process project for components & finished devices. • Lead and implement complex projects including quality improvement initiatives. • Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems. • Lead Process/Design Risk Analysis (focusing on both Product Risk and Production Risk). • Lead multiple product Design Control activities for new product development efforts. • Provide leadership in understanding of the quality regulations to other disciplines, providing guidance to R&D engineers and supporting their technical writing capability. • Lead multiple product Design Control activities for new product development efforts. • Support Process/Design Validation/Verification activities and approach. • Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting. • Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing. Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. Location: Sharon District - Israel (On-site)