Senior R&D Test engineer

Capstan Medical • Santa Cruz, CA

7d • Hybrid

About The Position

Capstan Medical is developing a less invasive approach to heart valve repair and replacement by combining surgical robotics, catheter-based technology, and next-generation implants. The Senior R&D Test Engineer will own testing for the hardware of a novel robotic platform and help strengthen the hardware testing strategy in support of an initial product release. This is a hybrid position requiring an average of four days per week at the Santa Cruz, California location.

The role develops verification and validation plans, translates hardware requirements into test methods and acceptance criteria, and leads design verification testing, including reliability and mechanical testing against IEC 60601-1. The engineer designs or improves test fixtures, collaborates with manufacturing on fixtures for production qualification, and prepares protocols and reports to support regulatory submissions. The position also involves communicating findings, contributing to root-cause and failure investigations, documenting work through design reviews and released documents, and aligning testing priorities with company goals.

Requirements

• Bachelor’s or master’s degree in Mechanical Engineering or a related engineering discipline, or equivalent work experience.
• 5–8 years of relevant experience in a regulated environment with formal verification testing; medical device experience is strongly preferred.
• Proficiency in CAD for creating detailed parts, assemblies, and drawings for test fixtures; SolidWorks is preferred.
• Ability to use GD&T as appropriate.
• Hands-on prototyping capabilities and familiarity with sensing equipment such as Chatillon or Instron.
• Strong written communication skills, particularly the ability to write technical content for reviewers such as the FDA.
• Comfort working with high levels of ambiguity and converting ambiguity into tangible outcomes.

Nice To Haves

• Experience with manufacturing methods and hands-on prototyping, including manual machining and 3D printing.
• Experience with medical robotics, particularly testing hardware to IEC 60601-1.

Responsibilities

• Develop high-level verification and validation test plans for robot hardware systems.
• Translate robot hardware requirements into test methods, test cases, and acceptance criteria.
• Own and lead execution of design verification test protocols, including system reliability testing and mechanical testing against IEC 60601-1.
• Coordinate with external test houses for IEC 60601-1-related mechanical testing as appropriate.
• Write test protocols and reports that accurately and clearly represent results for FDA submissions.
• Design test fixtures for verification testing and identify existing fixtures and methods that could be improved.
• Collaborate with manufacturing to design test fixtures for qualifying robot hardware in manufacturing.
• Identify and communicate issues and observations to the broader team.
• Collaborate with the team on root-cause analysis and failure investigations.
• Document and communicate work through design reviews and released product-development documents, as appropriate.
• Align individual work with company goals, identify high-risk items, and help develop solutions.

Benefits

• Medical, dental, and vision coverage at 100% for the employee and family.
• Flex time off.
• Collaborative, hands-on work environment and office outings.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior