Director of R&D

Inquis Medical is seeking a Director of R&D to lead the design, development, and commercialization of catheter-based mechanical and aspiration thrombectomy systems for the PE/DVT space. This is a hands-on technical leadership role for someone who can move fluidly between bench-level engineering, design control rigor, and cross-functional program leadership. You will own the R&D roadmap for one or more platforms — from concept and IP strategy through verification/validation, animal studies, and FDA submission — while building and mentoring a growing engineering team.

KEY RESPONSIBILITIES

Technical & Product Leadership

• Lead design and development of catheter-based thrombectomy devices, including aspiration systems, mechanical/expandable clot-engagement elements, delivery catheters, and combination console/consumable systems.
• Own the technical roadmap for large-bore aspiration and mechanical thrombectomy platforms, balancing clot removal efficacy, blood loss management, deliverability/trackability, and procedural speed.
• Drive iterative bench testing, in-vitro clot models, and simulated-use studies to characterize device performance against competitive benchmarks.
• Provide hands-on engineering leadership on catheter shaft construction, braid/coil reinforcement, tip design, torque and pushability, extrusion, and material selection (e.g., Pebax, nitinol, PTFE liners).
• Partner with preclinical/clinical teams to design and execute GLP animal studies and support first-in-human and pivotal clinical evaluations.

Program & Process Management

• Manage R&D programs against timeline, budget, and quality objectives using structured design control (design inputs/outputs, risk management per ISO 14971, DHF management).
• Ensure full compliance with FDA QSR (21 CFR 820), ISO 13485, and applicable EU MDR requirements throughout the development lifecycle.
• Lead design reviews, risk assessments (dFMEA/pFMEA), and V&V planning and execution in partnership with Quality and Regulatory.
• Support 510(k), De Novo, or PMA submission strategy and respond to FDA information requests as the R&D technical lead.
• Manage relationships with contract manufacturers, extrusion/braiding vendors, and outside test labs.

Team & Cross-Functional Leadership

• Build, mentor, and manage a team of R&D engineers (mechanical, biomedical, materials) as the organization scales.
• Collaborate closely with Marketing, Clinical, Regulatory, Quality, and Operations to align product requirements with market needs and commercialization timelines.
• Partner with Intellectual Property counsel to identify, protect, and defend novel device architectures; contribute as inventor on patent filings.
• Present technical updates, risk assessments, and roadmap decisions to executive leadership and the Board as needed.

REQUIRED QUALIFICATIONS

• Bachelor's degree in Mechanical, Biomedical, or related Engineering discipline (Master's or PhD preferred).
• 10+ years of medical device R&D experience, with at least 4+ years in a people-management or technical leadership role.
• Direct hands-on experience developing catheter-based interventional devices — thrombectomy, embolectomy, aspiration, or closely related endovascular/neurovascular platforms strongly preferred.
• Demonstrated experience taking a device through the full development lifecycle: concept, prototyping, verification/validation, design transfer, and regulatory submission.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971, and IEC 60601 as applicable.
• Experience with catheter/delivery-system manufacturing processes (braiding, coiling, extrusion, reflow, bonding) and materials common to endovascular devices.
• Track record of successful animal study execution and/or clinical study support (GLP survival studies a plus).
• Strong project management skills with experience running programs in a fast-paced, resource-constrained startup or growth-stage environment.
• Excellent written and verbal communication skills; comfortable presenting to executives, investors, and physician KOLs.