Lead Manufacturing Engineer

Come join us to build an AI platform for accessible and personalized breast cancer screening to empower women with early detection of breast cancer. iSono Health is looking for a Lead Manufacturing Engineer to oversee all aspects of product manufacturing and operation collaborating closely with the engineering team 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. If you are bright, motivated, interested in cutting-edge healthcare technology and want to make an impact on the lives of millions of women around the world, iSono Health is a place for you.

What you do:

• 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.

Minimum Requirements:

• 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.

Preferred Requirement:

• Experience in electromechanical new product introduction (NPI).
• Background in ISO 13485 medical device manufacturing or a similar regulated industry.
• Experience collaborating with electrical and systems engineers to design automated PCBA test fixtures.
• Proficiency in process characterization and validation using statistical tools.

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;