Senior Software Engineer

Our client is seeking a Software Test Engineer / Software Engineer to support the development, validation, and testing of software systems used within a highly regulated medical device environment. This role will focus on software and system testing, connectivity validation, automation development, statistical analysis, and cross-functional collaboration across engineering teams.The ideal candidate will have strong Python programming skills, hands-on system and software testing experience, and exposure to wireless technologies including Bluetooth Low Energy (BLE) and Wi-Fi. Candidates should be comfortable leading technical projects, documenting activities within an FDA-regulated environment, and collaborating with multidisciplinary teams.Key Responsibilities

• Design, develop, test, debug, and maintain software applications, automation tools, and test solutions.
• Perform software, system, and integration testing activities to verify product performance and functionality.
• Develop and execute test plans, protocols, and automated test scripts.
• Validate software requirements and ensure traceability throughout the development lifecycle.
• Support BLE and Wi-Fi connectivity testing, troubleshooting, and validation activities.
• Conduct statistical analyses to evaluate software and system performance.
• Generate technical documentation including test reports, change requests, protocols, and engineering assessments.
• Investigate software issues, identify root causes, and implement corrective actions.
• Track development and testing activities using approved project management and tracking tools.
• Collaborate with Software Engineering, Systems Engineering, Quality, Regulatory, Manufacturing, and Program Management teams.
• Participate in process improvement initiatives to enhance development and testing efficiency.
• Lead or coordinate technical projects and cross-functional activities.

Work AuthorizationApplicants must be authorized to work in the United States without current or future sponsorship., * Bachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, Computer Science, Biomedical Engineering, or a related technical discipline.

• 5-8 years of experience with a BS degree, 3-6 years with an MS degree, or 0-3 years with a PhD.
• Strong Python programming experience.
• Experience with software testing and system-level testing.
• Experience developing and executing test protocols and validation activities.
• Understanding of software development lifecycle (SDLC) processes.
• Experience with statistical analysis and data evaluation.
• Experience working in cross-functional engineering environments.
• Strong written and verbal communication skills.
• Ability to provide real-world examples of work completed and technical contributions., * Medical device industry experience.
• FDA-regulated product development experience.
• Understanding of complaint handling, quality documentation, CAPA, or design controls.
• Experience testing Bluetooth Low Energy (BLE) products.
• Experience testing Wi-Fi-enabled systems and devices.
• Knowledge of software verification and validation methodologies.
• Experience leading projects or technical initiatives.
• Familiarity with regulatory and quality system requirements.

Interview Process

• 1-2 Microsoft Teams video interviews.
• Candidates must be able to clearly discuss their experience and provide specific project examples.
• Use of AI-assisted tools during interviews is not permitted.

Key Skills

• Python
• Software Testing
• System Testing
• Test Automation
• BLE Testing
• Wi-Fi Testing
• Statistical Analysis
• FDA-Regulated Environments
• Medical Device Software
• Verification & Validation
• Requirements Analysis
• Technical Documentation
• Project Leadership
• Cross-Functional Collaboration

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance