Reports to: Manager, Instrument Engineering
Workplace Type: Onsite
Who we are:
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 precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with 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!
The Opportunity:
The Senior R&D Test Engineer will drive an early delivery system architecture into a new generation – adapting and expanding a catheter-based delivery system’s capabilities to complement advancing robotic control. The candidate will work closely with the delivery system, robotics, and implant teams to ensure a holistic product design and development approach.
What you’ll do:
- Collaborate with clinical and design engineers to translate user needs and device requirements into test methods, test cases, and acceptance criteria.
- Develop high level verification and validation test plans for the delivery system.
- Own and lead execution of test protocols with support from the team for design verification testing including simulated use testing and benchtop testing.
- Design test fixtures needed to perform verification testing and identify pre-existing fixtures and test methods that could be improved.
- Design and build electromechanical fixtures to characterize and improve catheter performance. Communicate and efficiently capture design learnings for rapid iteration loops.
- Work alongside the design engineers to quickly test and provide direction during early stage development.
- Collaborate with manufacturing to design test fixtures to qualify devices in manufacturing.
- Identify and communicate any issues or observations to the broader team. Collaborate with the team on root cause analysis or failure investigations.
- Document and communicate your work through design reviews and as appropriate released documents as part of the product development process.
- Align individual work to best support company goals, identifying high risk items and being part of developing solutions.
What you’ll need:
- BS or MS in Mechanical Engineering or related engineering discipline, or equivalent work experience.
- 5-8 years of relevant experience is desired but alternative levels will be considered for the right candidate (medical device experience strongly preferred).
- Proficiency in CAD (SolidWorks preferred) for creating detailed parts, assemblies, and drawings for manufacturing, using GD&T as appropriate.
- Hands on prototyping capabilities and familiarity with sensing equipment (e.g. Chatillon, Instron)
- Ability to compile and analyze data with applicable software (e.g. Excel, Minitab, Python, Matlab)
- Comfortable working with high levels of ambiguity and an ability to convert that into tangible outcomes.
- Experience with medical device development processes, design control, design verification, and regulatory processes preferred.
Ways to stand out from the crowd:
- Experience with various manufacturing methods and hands on prototyping, including manual machining, 3D printing, molding, casting, laser welding, reflow, coatings, etc.
- Experience with steerable catheter constructs, surgical robotics, and micro mechanisms.
- Experience designing electromechanical test systems and any associated skills (e.g. Arduino, LabView, etc)
- Experience with Six Sigma tools (e.g. Measurement System Analysis, Gage Repeatability and reproducibility, Analysis of Variance, Design of Experiments, etc)
Why join us:
- We offer a fun, hands-on, 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.