Design Quality Engineer

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Company Description

Butterfly Network’s mission is to democratize healthcare by enabling universal access to superior medical imaging. We reinvented ultrasound technology by creating the world's first handheld, single-probe whole-body ultrasound system: the Butterfly iQ.This innovative technology reduces the cost of the traditional ultrasound system by miniaturizing it onto a single semiconductor silicon chip.

Butterfly harnesses the advantages of AI and cloud computing to deliver advanced imaging that is easy-to-use and built for the digital era.The Butterfly iQ and next-generation Butterfly iQ+ have received CE Mark and FDA clearance, and are being sold in hospitals and clinics around the globe.

Joining Butterfly Network is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.

Job Description

This important technical position is accountable for supporting new product development and sustaining product line activities and has direct influence on component, assembly, and final product quality.  This individual will interact on a daily basis with R&D, Program Management, Operations, Regulatory, Clinical, and Marketing to drive quality into the product design, advise cross-functional teams on risks and mitigations, and communicate quality metrics to continually improve and promote compliance to Butterfly’s QMS procedures as well as applicable laws, regulations and standards. 

As part of our team, your core responsibilities will be: 

  • Ensuring all Butterfly products meet and exceed customer needs as well as applicable regulations and standards
  • Providing quality leadership in the planning and progression of NPI programs: 
    • Advocate for exceptional customer experience through product quality, safety, design, reliability, and usability
    • Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files 
    • Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer, etc.
  • Partnering with the post-market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product’s lifecycle
  • Driving timely investigation and closure of product related complaints, CAPAs, and nonconformances, using appropriate failure analysis and statistical methods
  • Improving processes to ensure compliance to FDA 21 CFR 820, MDD/MDR, ISO 13485, ISO 14971 and Butterfly’s procedures
  • Collaborating with Quality Systems and cross-functional teams to implement electronic tools for documents management, bug tracking, etc. to promote efficiency and enhance effectiveness of the QMS.
  • Perform as an SME in internal and external audits and provide war room support
  • Provide support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
  • Promote a culture of quality throughout Butterfly 
  • Other Quality duties as assigned

Qualifications

Baseline skills/experiences/attributes:

  • Bachelor’s Degree, preferably in engineering or other STEM related field
  • Five or more years of hands-on experience performing as a Quality Engineer in a U.S. FDA and ISO 13485 medical device regulated environment
  • Demonstrated competency in U.S. FDA medical device regulations (21 CFR 820) and international standards (ISO 13485, ISO 14971, IEC 62304, IEC 60601 and MDD/MDR)
  • Excellent leadership, communication, collaboration, teamwork and interpersonal skills
  • Superb ability to effectively communicate with all levels of the organization 
  • Occasional travel may be required based on business need

Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):

  • Experience with 510k and/or PMA submissions 
  • ASQ CQE, CSQE, or CQA certification preferred
  • ISO 13485 Lead Auditor certification
  • Understanding of SW Development Lifecycle, SW Architecture, and Configuration Management
  • Regulatory submissions for SaMD, AI/ML, cloud-hosted or digital health mobile apps
  • Proficient with software development and collaboration tools (e.g., Jira, JAMA, GitHub)
  • Experience with medical device HW testing (IEC 60601, IEC 60529, ISO 15223)

You Deeply Identify with Core Butterfly Network Values:

  • Efficient & Speedy - you get work done in a fraction of the time as industry peers 
  • Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
  • Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
  • Team Oriented - you celebrate and take joy in the success of others on the team

Additional Information

We offer great perks: 

  • Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
  • Pre-tax commuter benefits - we make your commute more reasonable 
  • Free onsite meals + kitchen stocked with snacks
  • 401k plan - we facilitate your retirement goals
  • Flexible Paid Time Off - recharge and come back ready to make an impact
  • Beautiful office in Palo Alto
  • Competitive salaried compensation - we value our employees and show it 
  • Equity - we want every employee to be a stakeholder
  • The opportunity to build a revolutionary healthcare product and save millions of lives! 

Butterfly network does not accept agency resumes.Butterfly Network Inc. is an E-Verify Company and is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

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Location

3-130 Palo Alto Square, 3000 El Camino Real, Palo Alto, CA 94306

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