iSono Health · 1 day ago
Manufacturing Engineer
Sunnyvale, CA
Full-time
Onsite
Mid Level
3+ years expiSono 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. 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 while ensuring compliance with regulatory standards.
Artificial Intelligence (AI)Health CareMedical Device
Responsibilities
Define and establish manufacturing processes, procedures, and production layouts for parts and assemblies, ensuring regulatory compliance.incorporate
Provide hands-on leadership, on-the-job training, and technical support for production staff on the production line during production ramp-up
Develop and incorporate inspection and test requirements into production plans through the development of process FMEA and other applicable Risk Management documents
Design and develop test fixtures for engineering and manufacturing applications
Define the asMaster 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 well as field returns; initiate corrective actions to ensure product quality
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 metrics and KPIs regularly
Significant exposure to the board and management team, as well as the industry-leading investors and thought leaders
Travel up to 20% as a regular basis
Qualification
Required
Bachelor's degree in mechanical, biomedical, industrial, or materials science engineering (preferred)
Minimum 3+ years of experience in medical device manufacturing
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
Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality
Preferred
Experience in electromechanical new product development
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
Company
iSono Health
iSono Health develops an AI platform for accessible and personalized breast health monitoring
11-50 employees
H1B Sponsorship
iSono Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Early StageTotal Funding
$6.45MKey Investors
JSK InvestmentsNational Science FoundationFoothill Ventures
2025-10-13Series Unknown
2025-03-26Seed· $1.84M
2019-09-18Grant· $0.77M
Leadership Team
Maryam Ziaei
Co-Founder
Shadi Saberi
CTO, Co-Founder
Recent News
2026-01-16
Company data provided by crunchbase