Staff R&D Test Engineer

Work Flexibility: Hybrid

Position Summary:

This role will drive development & execution of test methods for a next generation neurovascular products used for Hemorrhagic & Ischemic Stroke procedures. The position requires close collaboration with cross-functional teams to ensure alignment among various stakeholders on the project. This role involves hands-on work to support the development & validation of test methods, leverage engineering principles and drive innovation in the neurovascular field.

The successful candidate must excel in a focused, high-energy small-team environment. The position will require close partnership with cross-functional teams, including but not limited to product development teams, preclinical team, quality, and regulatory teams.

Quick learning and a desire to understand requirements from a clinical and design perspective are essential to become a valuable Test R&D engineer. A proven sense of mutual responsibility and shared reward is required. You will understand the product from both a technical perspective and the user's viewpoint, and drive definition and development of robust test strategy, as well as recommend design & process improvements.
 

Who we want:

• Analytical problem solvers:  People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers:  People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Curious learners:  People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
• Goal-oriented engineers: Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Effective communicators: People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you will do:

• Develop, execute, and document test protocols and reports to support product development, verification, validation, and regulatory submissions
• Design and validate test methods, including Test Method Validation (TMV) and Gage R&R studies
• Analyze test data using statistical tools (e.g., Minitab, JMP) and lead structured problem solving for test or product-related issues
• Develop automated test setups and integrate computer vision systems where applicable to improve repeatability, traceability, and throughput
• Implement continuous improvement initiatives, leveraging lean principles and automation to reduce variability and testing cycle time
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to ensure test strategies align with project and compliance needs
• Support root cause investigations, CAPAs, and change control through structured test analysis
• Maintain and develop custom test fixtures and simulated-use models, ensuring physiological relevance for neurovascular applications
• Ensure all test activities are executed in compliance with applicable standards (e.g., ISO 10555, ISO 14971, ISO 13485, FDA 21 CFR Part 820)
• Analyzing test data, identify non-conformance trends, generate concise executive summaries, and recommend design improvements.
• Contribute to requirements discussions and provide inputs from test engineering perspective.
• Participate in design change reviews and provide feedback on test impact and regression analysis.
• Ensure quality of deliverables for self as well as the team
• Contribute to capability building by identifying potential areas and developing capabilities.

What you need:

• Education: B.S/B.Eng./MS/M.Eng/Ph.D in Engineering
• Proficient in test method development, Gage R&R, and statistical data analysis
• Experience with computer vision systems and integrating sensors or vision components in automated testing
• Hands-on knowledge of test equipment including Instron, pressure systems, flow loops, and tensile/fatigue testers
• Strong documentation practices and understanding of design control, risk analysis (ISO 14971), and validation procedures
• Strong problem-solving skills and debugging of complex mechanical and electromechanical systems.
• Effective interpersonal, communications skills and demonstrated track of having worked in a global team setup
• 3–6 years of experience in a medical device or other regulated environment

Preferred Qualifications

• Experience with catheter, stent, or guidewire-based devices, ideally in neurovascular or cardiovascular domains
• Familiarity with LabVIEW, MATLAB, or Python for data acquisition and control
• Experience with SolidWorks or similar CAD for fixture development
• Strong verbal and written communication skills for documentation and cross-functional collaboration
• Track record of continuous improvement, lean implementation, and automation of manual test procedures

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Travel Percentage: 20%