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Senior Design Quality Engineer

iSono Health LogoiSono Health


Date Posted

25 Jun, 2022

Salary Offered

Not Specified

Job Type

Full Time

Experience Required

3+ years

Remote Work

No

Stock Options

No

Vacancies

1 available


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

Minimum Requirements:

  • 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

Preferred Requirement:

  • 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

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;

About iSono Health

iSono Health Logo

AI-powered platform for Accessible and Personalized Breast Health…

Company Size: 6 - 10 People
Year Founded: 2016
Country: United States

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