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.
- 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.
- 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.
- 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.
- 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;