Senior Design Quality Engineer

1 month ago


San Francisco CA, United States iSono Health Full time

Full Time] Senior Design Quality Engineer at iSono Health (United States) | BEAMSTART Jobs Senior Design Quality Engineer
iSono Health United States
Full Time
Remote Work
Stock Options
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 Senior Quality Engineer to help us drive our quality mission by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process.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.
Support company product development and design changes activities in compliance with company's Quality System focusing on DFX and assess the reliability of new designs.
Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer, etc.
Create quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices utilizing clinical and engineering knowledge
Perform deep technical failure analysis based on the physics of failure.
Advocate for exceptional customer experience through product quality, safety, design, reliability, and usability
Bachelor's degree in Mechanical Engineering or Electrical engineering
Minimum of 5 years of hands-on experience working in medical device industry
Experience with medical device HW, FW and SW testing (IEC 60601, IEC 62304)
Must be able to work well with interdisciplinary teams and to project manage cross-functionally
Experience in design for reliability, manufacturability, serviceability
Understanding of SW Development Lifecycle, SW Architecture, and Configuration Management
Proficient with software development and collaboration tools (e.g., Competitive salary and generous stock option plan;
Medical, dental and vision insurance;
Opportunities to attend major scientific conferences and publish research papers;
Awesome office located in South San Francisco with shuttle to BART and Caltrain;
AI-powered platform for Accessible and Personalized Breast Health…
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