iSono Health

AI-powered platform for Accessible and Personalized Breast Health…

Director of Manufacturing

Location
South San Francisco, CA
Job Type
Full-time
Experience
6+ years
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Shadi Saberi
Shadi Saberi
CTO

About the role

Come join us to build an AI-driven platform for accessible and personalized breast imaging to empower women and physicians with early detection of breast cancer.

iSono Health is looking for a Director of Manufacturing to join our growing team to lead the manufacturing activities for our products. In this position, you work closely with CMs to plan production timeline, budget and sourcing as well as our HW team to design and validate test fixtures and verify processes used during assembly and production.

Responsibilities:

  • Manage BOM as well as design and manufacturing changes with minimum impact on product launch timeline.
  • Provides product and process DFx input to Engineering to enhance manufacturability and product cost.
  • Defines inspection and test requirements and designs custom test fixtures for manufacturing reliability.
  • Establish supply chain requirements and qualify part manufacturers and suppliers
  • Perform failure analysis of non-conformant production components; initiate CAPA to ensure product quality.
  • Establish manufacturing processes, measurement test plans, GR&R reports, and process capability analysis.

Minimum Qualifications:

  • Bachelor’s degree in Mechanical, Manufacturing, Industrial or Materials Science Engineering preferred.
  • 5+ years of experience in a manufacturing role.
  • Proficiency with CAD software (e.g. SolidWorks, Pro-Engineer).
  • Demonstrated understanding of manufacturing processes (i.e. injection molding, machining)
  • Strong foundation in fabrication, and assembly of complex electromechanical assemblies
  • Strong technical skills in tooling development, process engineering, and troubleshooting.
  • Strong communication skills to interface with technicians, engineers, QA/RA, and suppliers.

Preferred qualifications:

  • Electromechanical new product development experience preferred.
  • Experience in ISO 13485 medical device manufacturing or similar regulated industry.
  • Experience working with system engineers to design automated PCBA Test Fixtures.
  • Experience in process characterization and validation using statistical tools
  • Six Sigma or Lean Manufacturing certification.

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;

Why you should join iSono Health

iSono Health is developing a platform that combines automated 3D ultrasound technology with cloud computation and artificial intelligence to empower women and their physicians with early detection of breast cancer. 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
Founded:2016
Team Size:9
Location:San Francisco
Founders
Shadi Saberi
Shadi Saberi
CTO
Maryam Ziaei
Maryam Ziaei
|CEO