Apply on Employer Site

Flow Medical · 3 hours ago

Director of Research and Development

United States

Full-time

Remote

Director/Executive

Flow Medical is a Chicago-based medical device startup company focused on developing innovative catheter-directed therapies for pulmonary embolism treatment. The Director of R&D will lead the development of the Flow Medical PE Catheter system, overseeing critical milestones from design verification to first-in-human use and beyond, while ensuring compliance with regulatory requirements and managing project risks.

Health CareMedicalMedical Device

Hiring Manager

Jayma Sanderson

Responsibilities

Own technical leadership of a next-generation, multi-function pulmonary embolism thrombolysis catheter system, encompassing the catheter, software, and display components, from late development through first-in-human use

Work closely and regularly with Flow Medical’s executive leadership team based in Chicago, including in-person collaboration as needed to support program alignment, decision-making, and milestone execution

Operate within Flow Medical’s virtual development model, functioning as a team of one internally while managing and coordinating a broad network of external engineering consultants, suppliers, and Flow Medical’s contract manufacturer to execute development, testing, and manufacturing activities. Ensure the PE catheter system is in full compliance with Quality and Regulatory requirements, including design controls, risk management and audit-ready documentation for DE submission

Deliver investigational clinical devices that are suitable for human use, while advancing design-for-manufacturing to support future scale-up and commercialization

Proactively identify, assess, and mitigate technical, operational, and programmatic risks that could impact clinical timelines, regulatory success, or business viability

Manage R&D budgets, resources, and external spend to achieve key development milestones efficiently while maintaining technical rigor and strategic flexibility

Qualification

FDA regulatory milestonesDesign ControlsRisk ManagementCatheter-based devicesVirtual development modelsProject managementCollaborative communication

Required

Experience leading medical device development projects through FDA regulatory milestones (Class II or greater)

Proven experience with Design Controls, Risk Management (ISO 14971) and IDE Submissions

Technical expertise in catheter-based and/or complex medical devices incorporating hardware, software, and user interfaces

Excellent project management skills with demonstrated ability to balance technical rigor, timelines, and budget constraints

Proven ability to operate effectively in an early-stage, resource-constrained environment, with comfort making decisions amid ambiguity and evolving requirements

Experience working within virtual or hybrid development models, managing consultants, suppliers, and contract manufacturers as an extension of the internal team

Highly collaborative communication style, with the ability to work closely with executive leadership, physician partners, and cross-functional stakeholders