Job requirements and application form

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)

• Bachelor’s Degree in Engineering required. • Minimum 5 years of proven experience in Design Quality Assurance (DQA) within a Medical Device company (FDA / CE regulated) – Must. • Strong expertise in Risk Management (ISO 14971) – proven capability in Product Risk and Production/Process Risk. • Demonstrated experience in driving Design Control activities for new product development (NPD/NPI). • Proven ability to mentor, guide, and support R&D teams in design documentation and quality processes. • Strong cross-functional communication and leadership skills; ability to push projects forward and maintain project schedules. • Knowledge of FDA QSR / QMSR, ISO 13485, EU MDR, and ISO 14971. • Knowledge of statistics, DOE tools, and Six Sigma problem-solving tools – Advantage. Other Considerations: Up to 10% travel required.