Senior Medical Robotics Test Engineer - Hybrid, Santa Cruz

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

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.