Job Description

BioIntelliSense is seeking a talented Senior Verification Engineer to develop and execute comprehensive verification and validation activities for innovative medical devices incorporating wearable technology and Software as a Medical Device (SaMD) subsystems, ensuring the safety, efficacy, and quality of their products.

Responsibilities

• Develop verification plans and test protocols
• Define test cases and acceptance criteria
• Execute test protocols on hardware, firmware, and software
• Analyze test results and document findings
• Develop automated test scripts and frameworks
• Generate comprehensive test reports
• Maintain detailed records of verification activities
• Collaborate with development and cross-functional teams

Requirements

• Bachelor's or Master's degree in Engineering, Computer Science, or related field
• 3+ years of experience in medical device verification and validation
• Strong understanding of medical device regulations (ISO 13485, IEC 62304, FDA 21 CFR Part 820)
• Experience with verification methodologies
• Proficiency in scripting languages (e.g., Python)
• Familiarity with test management and defect tracking tools
• Excellent analytical and communication skills

Benefits

• No benefits