R&D Director, Head of Implants

Versa Vascular is an innovative medical device startup developing minimally invasive implantable solutions for the treatment of tricuspid heart valve disease. Our mission is to improve patient outcomes through precision engineering, rigorous quality standards, and collaborative innovation. We are seeking an R&D Director with deep Class III implant experience to develop Versa's next generation of implants, and to support continued development and testing of existing products.

The Director should be a high integrity, dependable, open minded individual, comfortable working in the early stages of product development, collaborating cross-functionally between small teams across R&D, clinical, quality, regulatory and manufacturing.

The role has a focus on development and testing of cardiac implants. It is desirable that the candidate has prior background in structural heart product development to possess the experience and foundation to develop and test these novel systems from concept to product.

Foster the growth of the implant development team.

Define performance requirements for the Versa system to ensure patient safety, clinical success and market adoption. Lead development of implant to meet or exceed those requirements.

Take a detailed approach to management of implant development and testing timelines, track and communicate the status of test plans and results.

Apply systems-level problem solving at the intersection of the Versa delivery system, clinical, manufacturing, and quality programs.

Collaboratively establish goals to drive the existing Versa Vascular product to commercialization, working closely with the Implant team and counterparts in Delivery System, Operations, Clinical, Regulatory and Quality engineering.

Take a leadership role in the development of design verification and validation testing plans ensuring compliance to applicable standards, which might include structural reliability, biocompatibility, hydrodynamic performance testing, and chronic animal testing.

Develop and manage the inputs to risk management documents for the Versa system.

Collaboratively establish the implant product development roadmap for next generation Versa Tricuspid Repair products, integrating feedback from physicians, clinical, delivery system, and operations teams.

Adaptable, clear and concise verbal communication skills, which may include presenting to a team of engineers or the Versa Board of Directors.

Organized, clear, and effective written communication. Demonstrated capability in creation of technical reports and other documentation for regulatory submissions.

Familiar with the anatomical considerations and constraints for developing permanent implants in the structural heart space.

Experience with applicable testing standards such as ISO 5840 and ISO 5910:
Fatigue and Durability testing, Preclinical in‑vivo testing, SIM‑Use testing, Biocompatibility testing.

Deep knowledge of design considerations for structural heart implantables, such as:
Nitinol stent frames, ePTFE laminated components, fabric coverings for stent grafts, and loading systems.

Deep knowledge of various manufacturing methods, which may include metal and plastic machining, Nitinol laser cutting, shape setting, electropolishing, ePTFE lamination, sewing.

Experience with catheter based medical devices is strongly desired. Experience in ancillary systems and roles (i.e. delivery system, preclinical/clinical, operations, etc) is a plus.

Proficient in CAD, preferably Solid Works.

Hands‑on experience working within an ISO 13485 certified quality management system (QMS).

Proactive problem identification, and solution generation.

Curious, empathetic, and eager to learn!

Bachelors of Science degree in the field of engineering

10+ years in medical device R&D with at least 5 years in leadership

Proven history of taking a Class III implantable device through design controls to commercialization or human use

We offer a fun, fast‑paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.

We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.

We thrive in our work‑hard, play‑hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!