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;