Senior Director
Design Quality Engineering
Posted on 2/25/2023
Burlington, MA, USA
Experience Level
Desired Skills
Business Strategy
Product Design
  • 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
  • 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)
  • 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
Butterfly Network

501-1,000 employees

Medical imaging device manufacturer
Company Overview
Butterfly Network’s mission is to democratize healthcare by enabling universal access to superior medical imaging. The company has reinvented ultrasound technology that harnesses the advantages of AI and cloud computing to deliver advanced imaging that is easy-to-use and built for the digital era.
  • Health, dental & vision insurance
  • Equity
  • 401k
  • PTO
  • Flexible hybrid work
  • Parental leave
  • Home office stipend
  • Rewards & recognition program
  • LinkedIn Learning
Company Core Values
  • Focus
  • Dedication
  • Innovation