Manufacturing Engineer
About the role
Role focused on overseeing all aspects of product manufacturing and operation for iSono Health's AI-powered breast health platform. Involves designing, validating manufacturing/testing fixtures, refining processes, ensuring regulatory compliance, and supporting production lifecycle with a hands-on leadership approach.
Responsibilities
- Develop DFx (Manufacturing, Assembly) input to enhance manufacturability and product cost
- Define and establish manufacturing processes, procedures, and production layouts for parts and assemblies, ensuring regulatory compliance.
- Provide hands-on leadership and participate in assembly tasks on the production line during production ramp-up as needed to troubleshoot issues, validate process improvements, and support production goals.
- Serve as a technical resource for production staff, providing on-the-job training and support.
- Incorporate inspection and test requirements into production plans.
- Design and develop test fixtures for engineering and manufacturing applications.
- 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.
- Refine BOMs, workflows, and detailed work instructions to reduce manufacturing costs and increase efficiency.
- Inspect machinery, equipment, and tools to verify efficiency and investigate deficiencies; initiate corrective actions to ensure product quality.
- Provide technical support for failure analysis of discrepant production components, assemblies, and field returns.
- Offer strategic guidance to leadership on manufacturing build strategies, capacity expansion, and overall operations planning.
- Identify, research, develop, and qualify premier part manufacturers and suppliers; establish supply chain requirements and manage supplier relationships.
- Report on key manufacturing metrics and KPIs regularly.
- Travel up to 20% as required.
Qualifications
- Bachelor’s degree in mechanical, manufacturing, industrial, or materials science engineering.
- 5+ years of experience in a manufacturing role.
- Proficiency in CAD software (e.g., SolidWorks, Pro-Engineer).
- Strong understanding of manufacturing processes (e.g., injection molding, machining, stamping, laser welding, ultrasonic welding).
- Solid foundation in the design, fabrication, and assembly of complex electromechanical assemblies, including knowledge of mechanical assembly techniques and test methods (e.g., gage R&R analysis, DFx, and lean principles).
- Strong technical skills in prototyping, tooling development, process engineering, and troubleshooting.
- Excellent communication skills to effectively interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing, and supplier teams.
- Strong interpersonal skills with the ability to lead and inspire teams.
Skills
Benefits
- Competitive salary and generous stock option plan
- Medical, dental, and vision insurance
- Paid parental leave, vacation time, and sick time
- Opportunities to attend major scientific conferences and publish research papers
- Huge company vision to make an impact on global health
- Awesome office located in South San Francisco with shuttle to BART and Caltrain
About iSono Health
AI-powered platform for Accessible and Personalized Breast Health…
The iSono Health platform combines automated 3D ultrasound technology with cloud computation and artificial intelligence to empower women and their physicians with early detection and monitoring of breast cancer. Our patented compact ultrasound scanner captures 3D images through automatic scanning of whole breast volume in 1 min. The device connects to a smartphone/tablet/laptop and is controlled by our mobile app. The data is transferred to a secure cloud for image processing and storage. Our machine learning algorithm uses acoustic biomarkers to identify abnormal masses. Our platform’s automated operation and software expands ultrasound use in point-of-care diagnostics as well as monitoring of breast health at home, walk-in and mobile clinics. iSono Health offers women and healthcare providers : Safety: No Radiation Actionable Feedback with AI Fast: 2min Scan Easy to Use
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