R&D Engineer; Senior

Workplace type:
Hybrid – 4 days onsite, 1 day (Friday) remote

Description

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 a highly versatile R&D Engineer to develop Versa’s next generation of implants, and to support continued development and testing of existing products.

The engineer should be a high integrity, dependable, open minded individual, comfortable working in in the early stages of product development, collaborating cross-functionally between small teams across R&D, clinical, quality 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 to possess the experience and foundation to develop and test these novel systems from concept to product.

Responsibilities:

• Take a leadership role in developing test methods, creating test plans and executing design verification and validation testing of implant components, with the support of colleagues and experienced consultants, including: structural reliability, biocompatibility, hydrodynamic performance testing, and chronic animal testing.
• Design and process development of components of structural heart implantables, such as:
• Nitinol stent frames, ePTFE laminated components, fabric coverings for stent grafts, and loading systems.
• Develop and manage implantable component suppliers, contract testing groups and consultants to effectively meet project timelines. Track manufacturing transfers within various external suppliers from design freeze to product.
• Apply systems-level problem solving at the intersection of the Versa instrument, clinical, manufacturing, and quality programs.
• Take a detailed approach to management of implant development and testing timelines, track and maintain status of test plans and results.
• Work with manufacturing team to develop scalable manufacturing processes and reduce variability within existing processes. Develop and implement internal construction standards and inspections for sub-components and the final device.
• Develop and manage the inputs to risk management and product requirement documents for the Versa Implant sub-system.

Skills:

• Proficient in CAD, preferably Solid Works, including 3D design and creation of technical prints, including complex tolerance analysis.
• Experience with various manufacturing methods, which may include metal and plastic machining, Nitinol laser cutting, shape setting, electropolishing, ePTFE lamination, sewing, and MIM.
• Hands on prototyping and testing experience, which may include familiarity with laser cutting, 3D printing, silicone casting, and force sensing equipment (i.e. Chatillon, Instron).
• Organized, clear, and effective written communication. Demonstrated capability in creation of manufacturing instructions, technical reports, and other documentation.
• 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.
• Hands-on experience working within a quality management system (QMS).
• Strong communication and collaboration.
• Proactive problem identification, and solution generation.
• Experience with catheter based medical devices is strongly desired. Experience in ancillary systems and roles (i.e. catheter design, preclinical/clinical, operations, etc) is a plus.
• Curious, empathetic, and eager to learn!

Requirements:

• Bachelors of Science degree in the field of engineering
• 5+ years experience in an engineering role or equivalent
• Experience working on an implantable medical device is preferred

Why Join Us:

• 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!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.

We look forward to hearing from you.

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