Senior R&D Test engineer

Capstan Medical, Inc.•Santa Cruz, CA

9d•Hybrid

About The Position

Capstan Medical is seeking a Senior R&D Test Engineer to own testing for the hardware of a novel robotic platform and help strengthen its hardware testing strategy ahead of the initial product release. This hybrid position requires an average of four days per week at the company’s Santa Cruz, California location. The role develops and executes hardware verification and validation activities, documents results for regulatory submissions, and collaborates across product development and manufacturing.

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 conducting formal verification testing.
Proficiency in CAD, preferably SolidWorks, for creating detailed parts, assemblies, and test-fixture drawings, using GD&T as appropriate.
Hands-on prototyping capabilities and familiarity with sensing equipment such as Chatillon and Instron.
Strong written communication skills, particularly the ability to write technical content for a reviewer audience such as the FDA.
Comfort working with high levels of ambiguity and converting ambiguity into tangible outcomes.

Nice To Haves

Medical device experience.
Experience with various manufacturing methods and hands-on prototyping, including manual machining and 3D printing.
Experience with medical robotics, particularly hardware testing 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 design verification test protocol execution, including system reliability testing and mechanical testing against IEC 60601-1.
Coordinate with external test houses on 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 test methods that could be improved.
Collaborate with manufacturing to design fixtures for qualifying robot hardware in manufacturing.
Identify and communicate issues and observations to the broader team, and collaborate on root cause analysis and failure investigations.
Document and communicate work through design reviews and, as appropriate, released documents within the product development process.
Align individual work with company goals, identify high-risk items, and contribute to developing solutions.