R&D Engineer II or Senior R&D Engineer – Implant (based upon experience)
Engineering
|
Santa Cruz, CA
Hiring Manager: Spencer Noe, Director of Implant Engineering
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Capstan Medical is seeking R&D engineering candidates to design and test next generation mitral and tricuspid valve replacements. The engineer should be a high integrity, dependable, open minded individual, comfortable working in cross functional team environment interfacing between R&D, clinical and manufacturing teams.
This engineer will be responsible development of tissue based heart valves with a focus on testing and tissue development. The candidate will be responsible for defining and executing a DV test strategy, define test procedures to support development, ensure product requirements are met, and support overall compliance. Through this process its expected the engineer will identify and incorporate design and manufacturing improvements to the product. This person will facilitate engineering processes and product transfer to a cleanroom manufacturing environment.
Its desirable the candidate has a prior background in structural heart in order to possess the experience and foundation to develop and test novel heart valve replacement implants from concept to product.
Responsibilities
- Develop test methods, create test plans, and execute design verification testing of implant and/or sub-components.
- Assist in development of product specifications and test strategies to support overall compliance.
- Design and process development of sub-components of structural heart implantables, such as:
- Tissue Processing
- Valve/Leaflet Design
- 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 or final device.
Skills
- Proficient in CAD, preferably SolidWorks, including 3D design and creation of technical prints
- Experience with various manufacturing methods, including 3D printing
- Hands-on experience working within a quality management system (QMS)
- 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 & Durability Testing
- Preclinical in-vivo Testing
- Sim-Use Testing
- Biocompatibility Testing
- Design and build custom fixtures and test equipment.
- Experience in ancillary systems and roles (i.e. catheter design/construction, preclinical/clinical, systems integration, etc.) is a plus.
Requirements
- Bachelors of Science degree in the field of engineering
- Minimum 4-6 years experience in an engineering role or equivalent
Overview
Capstan Medical: Creating a new standard for minimally invasive structural heart treatment
At Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz, this gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment.