Company Description

Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission is to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly created the world's first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. 

The company has continued to innovate, leveraging the benefits of Moore’s Law, to launch its second generation Butterfly iQ+ in 2020, and third generation iQ3 in 2024 – each with increased processing power and performance enhancements. 

The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world.

Joining Butterfly 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:
  •  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.
• Ensuring all Butterfly products meet applicable regulations and certification standards
• Ensuring all Butterfly products meet and exceed customer needs
• Providing quality leadership in the planning and progression of NPI programs:
• 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 1497, IEC 62304 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:

• BS degree in Engineering or Technical Field or equivalent experience
• Min 6 years of Medical Device Design Quality experience
• Ability to work in a fast paced/time driven environment
• Ability to work in a geographically diverse business environment
• Ability to operate in an electronic Quality Management System
• Ability to leverage and/or engage others to accomplish projects
• Ability to work independently as a Design Quality Project Lead for Products
• Experience with root cause identification and problem solving
• Strong organizational and follow-up skills, as well as attention to detail
• Excellent interpersonal and communication skills, both written and oral to effectively communicate at multiple levels in the organization
• Working Knowledge of current Regulations and Guidelines such as: GMP, ISO 13485; ISO 14971, FDA 21 CFR Part 820; (EU) 2017/745 (MDR), IEC 62304, IEC 62366-1, IEC 60601, TIR-57
• Knowledge of Waterfall and Agile methodology best practices
• Strong Knowledge of Statistical Methods
• Strong Understanding of SW Development and release lifecycle, SW Architecture, and Configuration Management
• Proficient with software development and collaboration tools (e.g., Jira, JAMA, GitHub)
• Experience with  SaMD, AI/ML, cloud-hosted, digital health, or mobile app medical devices
• ASQ (or equivalent) CQA, CQE or other certifications preferred
• Participate or Lead Medical Device Product or Process Audits (May require Travel)

You Deeply Identify with Core Butterfly Network Values:

• ASQ CQE, CSQE, or CQA certification preferred
• 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)

Location

At Butterfly we offer a hybrid work environment. Our offices offer kitchens stocked with snacks and beverages, comfortable work stations, and multiple opportunities to collaborate with your colleagues to build community

This role is Hybrid (two to three days a week in the office) and must be based in either our NYC or Burlington, MA office. 

Compensation 

Our estimated salary for this role based in NYC is between $130,000 - $140,000 + bonus + equity + benefits. Actual pay is determined by multiple factors such as location, skills, qualifications, experience and market demand. 

Additional Information

We offer great perks: 

• Fully covered medical insurance plan (with dental & vision) - as a health-tech company, we place great worth on our teams’ well-being
• 401k plan and match - we facilitate your retirement goals
• Work from Home - we offer a hybrid work environment, part time in the office and part time work from home
• Pre-tax commuter benefits - we make your commute more reasonable 
• Unlimited Paid Time Off + 10 Holiday Days a Year - recharge and come back ready to make an impact
• Parental Leave - for eligible employees, we provide a generous 10-week parental leave and additional 6-8 weeks pregnancy-related leave for birthing parents. 
• Competitive salaried compensation - we value our employees and show it 
• Equity - we want every employee to be a stakeholder
• Kitchen stocked with snacks and beverages
• 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. 

For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status.

Butterfly Network 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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