Manager, Design Quality Engineer  
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 breakthrough 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 the team on risks and standards, and communicate quality metrics to continually improve and promote compliance to Butterfly’s QMS procedures as well as applicable laws, regulations and standard. 

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

Enhance customer experience:

• Manage design quality team who are responsible for ensuring all Butterfly products meet and exceed customer expectations and regulatory requirements 
• Partner with the post-market team to develop and monitor product performance metrics and data to drive improvements in product design, usability, and reliability
• Responsible establishing a cross-functional risk management process throughout the product’s lifecycle 
• Drive timely investigation and closure of product quality related complaints, CAPAs, and nonconformances, using appropriate failure analysis and statistical methods
  

New product development:

• Develop team who will represent Quality on new product development programs; performing as internal advocates for exceptional customer experience through product quality, safety, design and reliability
• Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, etc.
• Improve and scale processes to ensure compliance with FDA 21 CFR 820, MDD/MDR, ISO 13485, and Butterfly’s Design Controls procedures
• Partner with cross-functional leaders to enable strategic and informed decision making to ensure timely and compliant delivery on product road map goals
  

Drive systemic improvements

• Perform as an SME in internal and external audits and provide war room support
• Represent Design Quality team in management review and executive presentations
• Partner with Quality System team to maintain a robust QMS, implementing tools to promote efficiency and enhance effectiveness
• Promote a culture of quality throughout Butterfly and develop subject matter expertise of direct reports
• 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 managing the Quality Engineering department and associated staff in a U.S. FDA and ISO 13485 medical device regulated environment
• At least 3 years recent supervisory experience managing and developing direct reports
• Demonstrated competency in U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, and 21 CFR 807) and international standard requirements (ISO 13485, ISO 14971, IEC 62304 and the Medical Device Directive/Regulations) 
• Excellent leadership, communication, collaboration, teamwork and interpersonal skills
• Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
• 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!):

• ISO 13485 Lead Auditor certification
• ASQ CQE and/or CQA, CQM certification preferred
• SW Engineering background or 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)
• Proficient with database programs and/or querying languages

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 overlooking the Flatiron building in NYC OR Beautiful office near the ocean-front in historic Guilford, Connecticut OR Beautiful office in the heart of Silicon Valley
• 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.