Senior Manager, Clinical Development and Validation

Butterfly Network•Burlington, MA

10d•Hybrid

About The Position

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.

Requirements

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) five years’ experience in diagnostic ultrasound with POCUS Market Expertise, current (RDMS, RVT, and/or RDCS) required. Special attention will be paid to applicants with multiple registries.
Excellent organization and time management skills.
Demonstrated Leadership capabilities
Self-motivated and a self-starter with ability to work with minimal supervision.
Ability to understand both the clinical and business needs of the customer and Butterfly Network respectively.
Ability to translate customer needs into clear product requirements for R&D is a must.
Ability to think about the application of diagnostic ultrasound in non-traditional ways is also a must.
Ability and willingness to travel

Nice To Haves

Multilingual with fluency in English (spoken and written)
Ability to work effectively in a team environment.

Responsibilities

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.