Senior Clinical Development Engineer

Posted Yesterday
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Santa Cruz, CA, USA
In-Office
Senior level
Hardware • Healthtech • Robotics • Manufacturing
The Role
Lead clinical development activities for a transcatheter medical robotics platform: design and pre-clinical testing, support clinical trials and data collection, analyze clinical data, collaborate with physicians and cross-functional teams, and assist technical documentation and regulatory-aligned processes.
Summary Generated by Built In

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone. 

Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career-defining work.


Hiring Manager: Manager of Clinical Development 

Description:

We are seeking a highly skilled and motivated Senior Clinical Development Engineer to join our team. As a Clinical Development Engineer, you will play a crucial role in the design, development, and implementation of Capstan Medical’s medical robotics technology for transcatheter structural heart procedures. This role offers an exciting opportunity to contribute to groundbreaking advancements in minimally invasive cardiac interventions and make a significant impact on patient care. 

Responsibilities

    • Collaborate with cross-functional teams to design, test, and refine medical robotics systems for transcatheter structural heart procedures. 

    • Conduct pre-clinical evaluations and assessments to validate the safety, efficacy, and performance of Capstan Medical’s technology. 

    • Collaborate with clinical field team to model Support clinical trials by implementing and monitoring data collection processes, ensuring compliance with regulatory requirements and ethical standards. 

    • Analyze and interpret clinical data to identify trends, insights, and potential areas for improvement. 

    • Collaborate with physicians, surgeons, and other healthcare professionals to gather feedback and insights for product refinement. 

    • Stay up-to-date with the latest advancements and best practices in medical robotics and transcatheter structural heart procedures, and apply this knowledge to enhance Capstan Medical’s technology. 

    • Assist in the preparation of technical documentation, including reports, publications, and presentations. 

Skills

    • Strong understanding of medical robotics and transcatheter structural heart procedures, with a focus on minimally invasive interventions. 

    • Proficiency in DICOM analysis software. 

    • Excellent analytical and problem-solving skills, with the ability to interpret complex data sets. 

    • Strong communication and interpersonal skills to effectively collaborate with cross-functional teams, healthcare professionals, and stakeholders. 

    • Ability to work independently, manage multiple tasks simultaneously, and thrive in a fast-paced environment. 

    • Knowledge of regulatory requirements, including FDA guidelines for medical device development, is a plus. 

Requirements

    • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. 

    • 5+ years of experience in the medical device industry, particularly in clinical development, is highly desirable. 

Why join us:

    • We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients 

    • 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.

Skills Required

  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field
  • 5+ years of experience in the medical device industry, particularly in clinical development
  • Strong understanding of medical robotics and transcatheter structural heart procedures (minimally invasive)
  • Proficiency in DICOM analysis software
  • Knowledge of regulatory requirements, including FDA guidelines
  • Excellent analytical and problem-solving skills, able to interpret complex data sets
  • Strong communication and interpersonal skills for cross-functional and clinician collaboration
  • Ability to work independently, manage multiple tasks, and thrive in a fast-paced environment
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The Company
82 Employees
Year Founded: 2020

What We Do

Capstan Medical is a developer of robotic-enabled, minimally invasive solutions for treating structural heart disease. By merging surgical robotics with catheter-based technology and next-generation implants, the company aims to provide a patient-optimized approach to repair and replace heart valves, offering a significantly less invasive alternative to traditional open-heart surgery to improve patient outcomes and reduce recovery times.

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