Capstan Medical
Sr. R&D Test Engineer – Delivery Systems
Capstan Medical, California, Missouri, United States, 65018
Overview
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Sr. R&D Test Engineer – Delivery Systems
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Capstan Medical . Reports to:
Manager, Instrument Engineering . Workplace Type: Onsite. 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 technology offers a less invasive alternative to traditional open-heart surgery with precise and reliable placement of the heart valve implant. We aim to reduce recovery time and minimize complications, supported by a team of heart valve device experts and robotics engineers focused on a transformative solution for heart valve care. Capstan Medical is based in Santa Cruz, positioned to access Bay Area talent in a conducive environment for creative work. 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 R&R, ANOVA, DOE). Why Join Us
We offer a fun, hands-on, fast-paced, collaborative environment working on transformational technologies in the cardiac healthcare space. Outstanding benefits with medical, dental, and vision covered at 100% for you and your family, plus flex time off. We maintain a work-hard, play-hard culture with opportunities for biking, running, or office outings. 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, disability, or other legally protected status.
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Join to apply for the
Sr. R&D Test Engineer – Delivery Systems
role at
Capstan Medical . Reports to:
Manager, Instrument Engineering . Workplace Type: Onsite. 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 technology offers a less invasive alternative to traditional open-heart surgery with precise and reliable placement of the heart valve implant. We aim to reduce recovery time and minimize complications, supported by a team of heart valve device experts and robotics engineers focused on a transformative solution for heart valve care. Capstan Medical is based in Santa Cruz, positioned to access Bay Area talent in a conducive environment for creative work. 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 R&R, ANOVA, DOE). Why Join Us
We offer a fun, hands-on, fast-paced, collaborative environment working on transformational technologies in the cardiac healthcare space. Outstanding benefits with medical, dental, and vision covered at 100% for you and your family, plus flex time off. We maintain a work-hard, play-hard culture with opportunities for biking, running, or office outings. 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, disability, or other legally protected status.
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