Senior Validation Engineer

• Develop high level test plans, execute laboratory and validation testing and support engineering validation, trouble shooting, and continuous improvement activities.

• Design and develop test methods and test fixtures (adapters, and mech. Interface) to evaluate the performance and reliability of robotic components and subassemblies.

• Support the development of a supply chain strategy for robotic components that meet target costs and performance

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• Identifies, reports, and negotiates problems that arise during testing, and escalates new or persistent failure modes to appropriate engineering teams

• Support failure investigation and root cause analysis in collaboration with other engineering partners

• Clearly documents test results and observations in test report

• Plan and manage test bench utilization, equipment readiness and test schedules;

• Coordinate internal and external testing resources, including laboratories, suppliers and development teams

• Responsible for documentation of test methods and fixtures utilizing SolidWorks and Product Lifecycle Management systems

Skill/Job Requirements:

• Organizational skills and ability to manage deliverables under tight deadlines, set priorities, and manage time effectively.

• Possess a strong mechanical aptitude and a finely honed intuition for electromechanical design

• Strong analytical and problem-solving skills such as FEA, statistical, and experimental design

• Ability to perform mechanical engineering calculations needed to support equipment design or down selection, fixture design, including dimensional analysis.

• Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.).

• Exemplary communication and documentation skills with the ability to clearly present to larger groups and distill complex information.

• Highly proficient using CAD to design and document complex test equipment; SolidWorks preferred

Required Education and Training

• BS or MS in Mechatronics, Mechanical Engineering, Systems Engineering or related engineering or scientific discipline

• Minimum 5 years working with mechanical engineering products or relevant experience (Robotics experience preferred)

Preferred Skills and Experience

• Project management, planning, and changing management skills. Able to manage multiple fast-paced projects simultaneously.

• Experience with FDA QSR 21 CFR Part 820, ISO 13485, IEC 60601, and other related external standards.

• Experience with Good Documentation Practices (GDP)

• Experience working in medical devices or similar regulated industries