Senior Validation Engineer

Senior Validation Engineer -12 Months contract- May go permanent

• Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.
• Create and maintain various Design Control deliverables pertaining to the testing of the system including validation test plans; human factor validation protocols and summary test reports.
• Engage with Key Opinion Leaders to better understand the needs of all stakeholders interacting with the system and the operational environment of end users and patients. Observe clinical procedures, demonstrate prototypes and validate design with end-users.
• Apply in-depth knowledge of the operating room environment and medical technology to perform clinically relevant design validation testing to demonstrate that the device can be used safely and effectively in real-world use scenarios.
• Lead various design validation activities such as scheduling and preparing stimulated use environments, managing participant recruitment, defining risk-driven acceptance criteria for the tests, and coordinating all data collection efforts and analyses of results.
• Participate in various user-centric development activities to confirm user needs are met effectively in all aspects of device design, packaging, labeling and training.
• Build partnerships with various Robotics R&D partners such as Medical Education, Upstream and Downstream Marketing to strategize and mimic field-training in support of successful medical device launch.
• Proactively drive improvements into the Design Validation process that improves quality and reduces project and product risk.
• Keep abreast of industry best practices and recalls or challenges in relation to Design Validation to ensure our practices stay current and establish strategy for keeping the team up to date on latest advances in Design Validation.
• Mentor and train others on established Design Validation process and best practices.