Senior Manager, Clinical Development and Validation

About the role

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.

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 POCUS 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
• Create, maintain, and distribute 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
• Create and have 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

• 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
• 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 and willingness to travel

Specialized Skills

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