Senior Director, Design Quality Engineering

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

As part of our team, the Senior Director for Design Quality Engineering will be responsible for leading the day-to-day activities of the Design Quality team.  This role has direct influence on final product quality, managing the design quality engineers in new product development and sustaining product activities.  This individual will interact on a daily basis with Executive Management and cross-functional leaders to drive strategy and decisions on domestic and international commercial launches, drive quality into the product design, advise development teams on applicable standards and risks to continually improve product quality and compliance to Butterfly’s QMS procedures as well as applicable standards and regulations.

Principal Duties And Responsibilities:

• Leads the overall strategy development, implementation, and coordination of design quality activities for Butterfly.  Ensure alignment of design quality strategy to business strategy across all functional areas.
• Manage and coach the design quality engineers, investing time and energy to support, coach and mentor the team to help them to be as successful as possible and to support their professional development.
• Partner with cross-functional leaders to develop strategic plans for new product introductions and market expansion to ensure timely and compliant delivery on the product roadmap
• Develop processes and expertise within the organization to deliver robust Design History and Risk Management Files to support regulatory submissions for new product registration and throughout the product’s life cycle.
• Manage and organize the Design Quality department ensuring that departmental objectives are implemented in line with the overall budget
• Partner with the Post-Market Quality team and Supplier Quality to monitor sustaining product performance to drive improvements in product design, usability, and reliability.
• Partner with the Quality Management System team to ensure robust and reliable quality systems and alignment with design quality activities.
• Provide technical expertise for product development deliverables and activities, including requirements, risk, verification and validation, usability, statistical analysis, process validation, IQ/OQ/PQ, design transfer, etc.
• Represent the Design Quality team in management review and executive presentations.  Perform as an SME in internal and external audits and provide  support and preparation to the audit team.
• Promote a culture of quality and advocate the importance of product quality throughout the Butterfly organization.
• Other responsibilities as assigned.

Experience:

• Bachelor’s Degree (or non-US equivalent) required. Degree in engineering or other STEM related field preferred
• Minimum 7+ years experience in quality, regulatory, development, clinical affairs, or program management in medical device, IVD, or pharma industries. 
• Experience managing and leading a team is required
• A minimum of 10 years prior Design Quality / Quality Engineering experience with direct supervision of quality engineers, or equivalent leadership role required.
• Experience with regulatory submissions including 510(k), EU Technical Files, and ROW submissions is preferred.
• Advanced knowledge of FDA and EU regulations outside the US/EU.
• Outstanding interpersonal and communication skills for bridging technical and business participants, for negotiating timelines and for effective collaboration
• Mastery of relevant technical regulations, and ability to stay abreast of regulations pertinent to medical devices
• Mastery of product knowledge or equivalent/comparable systems
• Ability to strategically interpret and respond to requests from cross-functional teams, regulatory agencies, and suppliers

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

• SW engineering background and understanding of SW Development Lifecycle, SW Architecture, and Configuration Management
• Experience with regulatory submissions for SaMD, AI/ML, or digital health
• Proficient with software development and collaboration tools (e.g., Jira, JAMA, GitHub)

Location

At Butterfly we offer a hybrid work environment. For most employees, this means part time in the office (two or more days a week). Based on functional responsibilities and equipment needs, certain roles will  require full time on-site support, and select roles will be eligible to be remote. 

Our offices offer kitchens stocked with snacks and beverages, comfortable work stations, and multiple opportunities to collaborate with your colleagues to build community. 

This is a hybrid position and will be based out of our office in Burlington, MA. Our office is located near the Burlington Mall in an area called ‘The District’. You’ll have access to community spaces, including an 8,000 SF state of the art fitness center and the OMMM Yoga and Meditation Studio.

Benefits and 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
• Unlimited Paid Time Off + 15 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
• The opportunity to build a revolutionary healthcare product and save millions of lives! 

For this role, we may consider qualified applicants who need visa assistance.

Butterfly network does not accept agency resumes.

Butterfly Network Inc. is an E-Verify Company. 

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.