Manufacturing Engineer

About iSono Health Inc. iSono Health is a dynamic and rapidly growing early clinical-commercial stage medical device company dedicated to saving lives and transforming care through innovative robotics, AI, and 3D ultrasound technologies. At iSono Health, we're pioneering a new era of breast care. We believe every woman deserves access to fast, affordable, and comfortable screenings. That's why we developed ATUSA, the world's first AI-powered platform with a point-of-care, automated 3D ultrasound system. To succeed here, you need to think like an entrepreneur, act like a leader, and execute with precision. We value individuals who take initiative, embrace challenges, and are excited to wear multiple hats. Creativity, resilience, and a commitment to excellence are essential as we push the boundaries of what’s possible in healthcare. Our work is exciting because it’s meaningful. Together, we’re empowering women to take control of their health by expanding access to potentially lifesaving ultrasound technology. If you’re passionate about making a difference and ready to be part of a nimble, scrappy team that values impact over hierarchy, iSono Health is the place for you. At iSono Health, success isn’t just about the work—it’s about the mindset. We’re a small but mighty team of dedicated individuals driven by a shared mission: revolutionizing women’s health and making a profound impact for patients and clinicians. With big ambitions and innovative plans, we thrive in a fast-paced, dynamic environment where every team member owns what they build. Join us in transforming healthcare and be part of a team where every voice matters, every idea counts, and every action contributes to a greater purpose. About the role As the Manufacturing Engineer, you will oversee all aspects of product manufacturing and operation, collaborating closely with engineering teams and suppliers to establish efficient processes. Your role will involve designing, engineering, validating, manufacturing, and testing fixtures and documenting and refining reliable processes for component and system-level assemblies. You will also ensure compliance with regulatory standards, fostering efficiency and excellence throughout the production lifecycle. What you'll do Define and establish manufacturing processes , procedures, and production layouts for parts and assemblies, ensuring regulatory compliance . Provide hands-on leadership, on-the-job training, and technical support for production staff on the production line during production ramp-up. Define, implement, and continuously refine manufacturing KPIs and dashboards (yield, throughput, cycle time, cost/unit, scrap, on-time delivery), establishing clear methods to track performance and drive data-informed decisions. Lead scale-up of manufacturing operations , identifying bottlenecks, optimizing workflows, and building efficient, repeatable processes that support rapid growth while maintaining quality and regulatory compliance. Own capacity planning and production forecasting , translating demand into actionable production targets and quotas; leverage data analysis to improve efficiency, reduce costs, and ensure predictable, scalable output. Develop and incorporate . inspection and test requirements into production plans through t he development of process FMEA and other applicable Risk Management documents Design and develop test fixtures for engineering and manufacturing applications. Define the as Master Validation Plan and support validation builds and testing Oversee the complete documentation process for DMR and DHR, including manufacturing work instructions, inspection and test specifications, and travelers. Ensure accurate data entry and seamless management within the quality and MRP database platform. Identify process and design improvements to reduce manufacturing costs and increase efficiency. Provide technical support for failure analysis of discrepant production components, assemblies, equipment/tools, as