Director of R&D New Menlo Park, CA

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. Compensation Range $160,000 - $265,000 USDInquis Medical is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law. Inquis Medical does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.