Medical Devices, Verification and Validation Engineer

We're seeking a Product Verification and Validation Engineer to join our medical devices compliance team, focusing on wearables and Software as a Medical Device (SaMD). This role will be responsible for developing, implementing, and executing verification plans to ensure our products meet regulatory requirements and are safe and effective for users.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices. Your expertise will be crucial in ensuring the quality and reliability of our products, particularly in areas such as: Sensor validation: Working with advanced sensors, such as electrodermal activity (EDA) sensors, heart rate variability (HRV) sensors, and other physiological sensors. Algorithm validation: Verifying the accuracy and effectiveness of algorithms used in our wearables, such as those for stress detection, sleep tracking, and physical activity monitoring.* Interoperability testing: Ensuring seamless integration with other Meta products and services, such as Meta AI and other wearable devices.

Medical Devices, Verification and Validation Engineer Responsibilities:

• Develop and execute verification protocols for wearables and SaMD products, including testing plans, procedures, and reports
• Analyze test data, identify trends and anomalies, and provide insights to inform product design and development decisions
• Design and implement automated testing frameworks and tools to support efficient and effective verification activities
• Collaborate with cross-functional teams (R&D, Regulatory, Quality) to identify and mitigate risks associated with product design and development
• Support regulatory submissions and interactions with regulatory agencies, including 510(k) and other relevant submissions

• Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience
• 5+ years of experience in medical device system engineering or a related role
• Understanding and implementation of verification activities based on regulatory requirements (e.g., FDA, EU MDR, ISO 13485) and industry standards (e.g., IEC 62304)
• Experience with automated testing frameworks and tools
• Proven experience using analytical and problem-solving skills in particular with interpretation complex data sets

• Experience with Six Sigma tools (e.g. Measurement System Analysis, Gage Repeatability and Reproducibility, Analysis of Variance, Design of Experiments, etc)
• Certified Quality Engineer (CQE) or similar qualification
• Presenting and authoring documents, communications, and presentations to technical and cross functional stakeholders
• Experience interfacing with Food and Drug Administration or similar regulators or auditors