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 submissionsDesign and validate test methods, including Test Method Validation (TMV) and Gage R&R studiesAnalyze test data using statistical tools (e.g., Minitab, JMP) and lead structured problem solving for test or product-related issuesDevelop automated test setups and integrate computer vision systems where applicable to improve repeatability, traceability, and throughputImplement continuous improvement initiatives, leveraging lean principles and automation to reduce variability and testing cycle timeCollaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to ensure test strategies align with project and compliance needsSupport root cause investigations, CAPAs, and change control through structured test analysisMaintain and develop custom test fixtures and simulated-use models, ensuring physiological relevance for neurovascular applicationsEnsure 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 teamContribute to capability building by identifying potential areas and developing capabilities.

What you need:

Education: B.S/B.Eng./MS/M.Eng/Ph.D in EngineeringProficient in test method development, Gage R&R, and statistical data analysisExperience with computer vision systems and integrating sensors or vision components in automated testingHands-on knowledge of test equipment including Instron, pressure systems, flow loops, and tensile/fatigue testersStrong documentation practices and understanding of design control, risk analysis (ISO 14971), and validation proceduresStrong 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 setup3–6 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 domainsFamiliarity with LabVIEW, MATLAB, or Python for data acquisition and controlExperience with SolidWorks or similar CAD for fixture developmentStrong verbal and written communication skills for documentation and cross-functional collaborationTrack record of continuous improvement, lean implementation, and automation of manual test procedures

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Travel Percentage: 20%