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

The Post Market Surveillance, Data Analytics Lead is responsible for establishing and maintaining post market data analytics. Under the direction of the Global Director of Post Market Surveillance, the PMS Lead will ensure quality decisions are data-driven and customer-focused.   

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

• Building and maintaining a robust signal detection program with verified/validated data analysis tools to monitor post market performance of our medical devices through signal detection and statistical data analysis.
• Responsible for the continuous improvement of the post market surveillance program.
• Leading global cross-functional discussions related to product signals and program actions to ensure compliance and continual improvement.
• Collaborating cross-functionally during the product lifecycle of new product development to provide post market data and customer insights associated with existing products.
• Responsible for preparing metrics for Post Market Surveillance quarterly meetings, Management Review quarterly meetings, Monthly Complaint Trend Meetings, as well as CERs, PSUR Reports, Recalls and Regulatory Submissions as requested.
• Supporting the CAPA process and (when required) leading investigations associated with post market surveillance trending.
• Responsible for contributing to the continual quality of Butterfly Network’s process improvement initiatives.
• Ensuring that Post Market Surveillance procedures and practices are in compliance with global regulatory requirements.
• Responsible for performing tasks to support the quality system and quality policy as directed by Management.

Qualifications

Baseline skills/experiences/attributes:

• Bachelor’s Degree with 5-7+ years of experience in medical device post market surveillance, data analytics or equivalent experience
• Working Knowledge of ISO13485 / ISO 9001 / FDA QSR Part 820 & 803 / Health Canada / MMD and EU MDR requirements related to complaints, reporting and post market surveillance.
• Proficiency in statistical data analysis tools and techniques
• Excellent interpersonal skills
• Ability to work in a timeline driven environment
• Excellent communication skills, both written and oral, with experience presenting to executive level

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

• New Product Launches
• Transition from MMD to EU MDR Requirements
• Updating Clinical Evaluation Reports

Physical Demands/Work Conditions

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
• The ability to either work remotely or be based in one of our US offices in NYC, Palo Alto, or Guilford, CT
• 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.