Senior Manager, Clinical Development and Validation

About this role

Clinical Development and Validation, Manager

Company Description

Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging and sensing with its proprietary Ultrasound-on-Chip™ semiconductor technology and software solutions. Butterfly first proved its technology in the point-of-care ultrasound market – commercializing the world’s first single-probe, whole-body portable ultrasound device, which is now on its best-selling, third-generation: Butterfly iQ3™. The Company combines its advanced hardware with cloud software and AI, an enterprise workflow solution (Compass AI™) and other offerings to drive adoption of affordable, accessible ultrasound. Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative.

In addition to its medical imaging products, Butterfly Embedded™ is the Company’s Ultrasound-on-Chip™ licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Through Butterfly Embedded™, partners can build and scale novel ultrasound applications powered by Butterfly’s proprietary semiconductor chip and software platform. Butterfly’s innovations have been recognized by Prix Galien USA, Fierce 50, TIME’s Best Inventions and Fast Company’s World Changing Ideas, among other achievements.

We’re a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let’s build something extraordinary together!

Job Description

The Clinical Development Manager is responsible for contributing the clinical perspective from our Point of Care Ultrasound (POCUS) customers and translating those needs to define, develop, and validate valuable clinical solutions into commercial products and tools. They will be expected to initiate, run, and support software and product Integration testing and validation efforts through the development and product lifecycle. They will cultivate and maintain engaging relationships with leading POCUS influencers and will work closely to transfer clinical expertise with the Ultrasound Engineering (Imaging), Systems Engineering, Software, Deep Learning, Product, Marketing, and other cross functional teams to participate in validating design outputs, with opportunities for supporting design inputs. This role will support the product development teams in areas of product definition, product assessment, and product development.

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

• Assist with customer engagements, focus groups, user groups, advisory boards, and

• other market-related activities to assist in the collection, definition, and validation of

• commercial needs and requirements

• Work with clinical specialists, software, integration team, and systems engineering to

• take part in validating design outputs.

• Develop working knowledge of diagnostic and monitoring tools used by PoC physicians

• in their practice

• Identify and report clinical trends gleaned via scientific congresses, customer seminars,

• and education events

• Define, document, and execute Clinical Validation tests including maintaining

• traceability to requirements.

• Responsible for creating, maintaining, and distributing plans and reports promptly and timely to support product development timelines.

• Participate in system life cycle and software integration testing.

• Participate in reviews and improvement of requirements, design documents, and overall

• process.

• Responsible for creating and having input to specific documentation, i.e., Product

• Requirements Definition, Clinical Evaluation Report (CER), Clinical Validation Plan and

• Report.

• Accountable for carrying out the requirements of Butterfly Network’s quality procedures.

• Provide clinical support and input cross-functionally to the design and development

• process as needed.

• Provide product support to Commercial, Marketing, Clinical Application and other cross functional teams

• Perform a broad variety of tasks in support of the role and responsibilities.

Qualifications

Baseline skills/experiences/attributes:

• Minimum of 3 years of R&D experience or equivalent.

• Bachelor degree in Biomedical or Ultrasound preferred.

• Minimum of 5 years of experience utilizing Ultrasound Medical Imaging and Medical

• Technologies in diverse clinical environments with a firm understanding of product

• attributes that lead to a positive User and Patient outcomes. ARDMS certified required.

• Must have at least (5) fiv