Senior R&D Test engineer

Capstan Medical, Inc.; Santa Cruz (CA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical benefits

Flex time off

Job summary

Capstan Medical, Inc. in Santa Cruz is seeking a Senior R&D Test Engineer to own hardware testing for a novel robotic platform. You will accelerate our testing strategy and contribute to a successful initial product release in a hybrid role with about four days per week onsite in Santa Cruz, CA.

You will develop verification plans, translate requirements into test methods, lead IEC 60601-1 testing, and collaborate across teams to ensure robust test fixtures and documentation for FDA submissions.

Qualifications

• BS or MS in Mechanical Engineering or related field, or equivalent work experience.
• 5-8 years in regulated environment with formal verification testing for medical devices.
• CAD (SolidWorks) for creating parts/drawings; GD&T.
• Hands-on prototyping and sensing equipment (e.g. Chatillon, Instron).
• Strong technical writing for reviewer audiences like the FDA.
• Comfortable with ambiguity and turning it into tangible outcomes.

Responsibilities

• Develop high level verification and validation test plans for robot hardware systems.
• Translate robot hardware requirements into test methods, cases, and acceptance criteria.
• Own and lead execution of test protocols for design verification testing including system reliability testing and IEC 60601-1.
• Write test protocols and reports to support FDA submissions.
• Design test fixtures for verification testing and improvements.
• Collaborate with manufacturing to design fixtures to qualify robot hardware.
• Document work through design reviews and released documents.

Skills

Mechanical engineering

Regulated testing experience

Written communication

Ambiguity management

Education

BS or MS in Mechanical Engineering

Tools

SolidWorks

GD&T

Job description

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 innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.

Capstan Medical is uniquely positioned in Santa Cruz. This gives us access to the amazing technical talent of the Bay Area, but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.

Come join us and become part of a team revolutionizing heart valve treatment!

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!

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.