Head of Catheter-Based MedTech R&D & Roadmap

Inquis Medical, Inc.; Menlo Park, Northern (CA, KY); Hybrid; USD 160,000 - 265,000; Full time

Job summary

Inquis Medical, Inc. seeks a Director of R&D to lead the design, development, and commercialization of catheter-based thrombectomy systems for the PE/DVT space. This hands-on leadership role bridges bench engineering, design control, and cross-functional program management.

You will own the R&D roadmap across platforms, from concept and IP strategy through verification/validation, animal studies, and FDA submissions, while mentoring a growing team.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or related Engineering.
• 10+ years of medical device R&D with at least 4+ years in a leadership role.
• Hands-on experience with catheter-based interventional devices such as thrombectomy or embolectomy.
• Experience taking a device from concept to regulatory submission.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971, IEC 60601.
• Experience with catheter/delivery-system manufacturing processes (braiding, coiling, extrusion).
• Track record of GLP animal studies and/or clinical study support.
• Strong project management in a fast-paced environment.
• Excellent written and verbal communication; able to present to executives.

Responsibilities

• Lead design and development of catheter-based thrombectomy devices, including aspiration systems and delivery catheters.
• Own the technical roadmap for large-bore aspiration and mechanical thrombectomy platforms.
• Drive bench testing, in-vitro clot models, and simulated-use studies to benchmark performance.
• Provide hands-on leadership on catheter shaft construction, braid/coil reinforcement, and material selection.
• Partner with preclinical/clinical teams to design and execute GLP animal studies and support first-in-human and pivotal evaluations.
• Manage R&D programs against timeline, budget, and quality objectives with design control.
• Ensure compliance with FDA QSR (21 CFR 820), ISO 13485, and EU MDR as applicable.
• Lead design reviews, risk assessments (dfMEA/pfMEA), and V&V planning with Quality/Regulatory.
• Support 510(k), De Novo, or PMA submission strategies and FDA responses.
• Manage relationships with contract manufacturers and external test labs.

Skills

Catheter-based device R&D

Leadership

Cross-functional collaboration

Design control

Bench testing

Education

Bachelor's degree in Mechanical/Biomedical Engineering

Master's degree (preferred)

PhD (preferred)

Tools

Braiding

Coiling

Extrusion

Job description

Inquis Medical, Inc. seeks a Director of R&D to lead the design, development, and commercialization of catheter-based thrombectomy systems for the PE/DVT space. This hands-on leadership role bridges bench engineering, design control, and cross-functional program management.

You will own the R&D roadmap across platforms, from concept and IP strategy through verification/validation, animal studies, and FDA submissions, while mentoring a growing team.