Senior Design Quality Engineer
About the role
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.
What you do:
- 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.
- Initiate, investigate, or coordinate CAPA's involving the products and internal or external processes
- Provide support for the internal and external audits as a member of the QA audit team.
- 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
- Must have working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366
- Experience with medical device HW, FW and SW testing (IEC 60601, IEC 62304)
- Must be detail orientated, well organized and have excellent written and oral communication skills.
- Must be able to work well with interdisciplinary teams and to project manage cross-functionally
- Ability to conduct product investigations, write reports and procedure manuals
- Strong analytic skills as proven by track record for analyzing and fixing complex problems
- Deep technical background in electromechanical devices and robotics
- Experience in design for reliability, manufacturability, serviceability
- ASQ CQE, CRE, CSQE, or CQA certification preferred
- Understanding of SW Development Lifecycle, SW Architecture, and Configuration Management
- Proficient with software development and collaboration tools (e.g., Jira, GitHub)
- Must have a solid understanding of statistical processes and techniques
- 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;
About 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.