BS or MS in Mechanical Engineering or related field, or equivalent experience.
5-8 years of experience in a regulated environment, preferably in medical devices.
Proficient in CAD software (SolidWorks preferred) for creating detailed designs.
Hands-on prototyping skills and familiarity with sensing equipment (e.g., Chatillon, Instron).
Strong written communication skills for technical documentation, especially for FDA submissions.
Ability to navigate ambiguity and produce clear, actionable outcomes.
Responsibilities
Develop high-level verification and validation test plans for robotic hardware systems.
Translate hardware requirements into test methods, cases, and acceptance criteria.
Lead execution of test protocols for design verification and reliability testing, coordinating with external test houses as needed.
Write test protocols and reports to support regulatory submissions, particularly for the FDA.
Design and improve test fixtures for verification testing in collaboration with manufacturing.
Identify and communicate issues, collaborating on root cause analysis and failure investigations.
Document work through design reviews and relevant product development documents.
Benefits
100% coverage for medical, dental, and vision for you and your family.
Flexible time off to promote work-life balance.
A collaborative, fast-paced environment focused on transformational cardiac healthcare technologies.
Opportunities for team-building activities and a fun office culture.
Full Job Description
Responsibilities
The Senior R&D Test Engineer will own testing for the hardware of a novel robotic platform and required to Come bring your experience to accelerate and strengthen our hardware testing strategy and be part of a successful initial product release. This is a hybrid position requiring 4 days per week on average at our Santa Cruz, CA location.
What you'll do:
Develop high level verification and validation test plans for the robot hardware systems.
Translate robot hardware requirements into test methods, test cases, and acceptance criteria.
Own and lead execution of test protocols for design verification testing including system reliability testing and mechanical testing against IEC 60601-1. Coordinate with external test houses for executing IEC 60601-1 related mechanical testing as appropriate.
Write test protocols and test reports to support regulatory in accurately and clearly representing our test results in FDA submissions.
Design test fixtures needed to perform verification testing and identify pre-existing fixtures and test methods that could be improved.
Collaborate with manufacturing to design test fixtures to qualify robot hardware 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.
Requirements
What you'll need:
BS or MS in Mechanical Engineering or related engineering discipline, or equivalent work experience.
5-8 years of relevant experience working in a regulated environment with formal verification testing, medical device experience strongly preferred.
Proficiency in CAD (SolidWorks preferred) for creating detailed parts, assemblies, and drawings for test fixtures, using GD&T as appropriate.
Hands on prototyping capabilities and familiarity with sensing equipment (e.g. Chatillon, Instron)
Strong written communication skills, in particular writing technical content for a reviewer audience like the FDA.
Comfortable working with high levels of ambiguity and an ability to convert that into tangible outcomes.
Ways to stand out from the crowd:
Experience with various manufacturing methods and hands on prototyping, including manual machining, 3D printing, etc.
Experience with medical robotics, in particular testing hardware to IEC 60601-1.
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!
