Medical Devices – Verification and Validation Engineer

Medical Devices – Verification and Validation Engineer

Requirements

• 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

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

Preferred Qualifications

• Experience working with medical device system verification and/or development
• Experience with Six Sigma tools (e.g. MSA, Gage R&R, ANOVA, DOE etc)
• Certified Quality Engineer (CQE) or similar qualification