Sr. Manufacturing Engineer
Not Disclosed•Full-TimeOn-site
location_on602, Santa Catalina Terrace, Sunnyvale, Santa Clara County, California, 94085, United States
About the Role
At iSono Health, we are changing the future of breast cancer detection. Our technology empowers clinics of all sizes to deliver fast, affordable, and comfortable breast imaging at the point of care, utilizing the world's first AI-powered, portable 3D ultrasound system.
As a Senior Manufacturing Engineer, you will play a pivotal role in bringing this life-saving innovation to the world. You will work on cutting-edge, FDA-cleared technology in a mission-driven environment where your contributions directly impact women's health. This role involves overseeing all aspects of product manufacturing and operation, collaborating closely with engineering teams and suppliers to establish efficient processes. You will design, validate, and refine reliable processes for component and system-level assemblies while ensuring compliance with regulatory standards.
Why Join Us?
We are a growing startup with a bold vision: to make early detection effortless and accessible for everyone. If you are excited to help scale a high-impact product, love solving complex challenges, and want your work to matter, this is the place for you. You will lead manufacturing strategy, improve production processes, and collaborate with a cross-functional team committed to quality, innovation, and accessibility.
Join us in transforming breast imaging and saving lives, one scan at a time.
Work location
Work model: On-site
602, Santa Catalina Terrace, Sunnyvale, Santa Clara County, California, 94085, United States
Sunnyvale, California
Key Responsibilities
- check_circleDefine and establish manufacturing processes, procedures, and production layouts ensuring regulatory compliance
- check_circleLead scale-up of manufacturing operations by identifying bottlenecks and optimizing workflows
Similar Job Opportunities
Skills, education and keywords
Skills: Solidworks, Pro-Engineer, Injection Molding, Machining, Stamping, Laser Welding, Ultrasonic Welding, Gage R&R Analysis, DFX, Lean Principles.
Education: Bachelor's degree in engineering fields preferred.
Frequently asked questions about Sr. Manufacturing Engineer at iSono Health
What does a Sr. Manufacturing Engineer at iSono Health do?expand_more
In this Sr. Manufacturing Engineer at iSono Health role, you will define and establish manufacturing processes, procedures, and production layouts ensuring regulatory compliance; lead scale-up of manufacturing operations by identifying bottlenecks and optimizing workflows; design and develop test fixtures for engineering and manufacturing applications; and develop inspection and test requirements through process fmea and risk management documents.
What are the requirements for this Sr. Manufacturing Engineer role?expand_more
To qualify for the Sr. Manufacturing Engineer at iSono Health position, applicants should have: Bachelor's degree in mechanical, electrical, biomedical, industrial, or materials science engineering; Minimum 5+ 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); Experience in electromechanical new product development; and Background in ISO 13485 medical device manufacturing or a similar regulated industry.