Summary
✨ AI‑Generated
A Software Quality Engineer II is sought to support the development of regulated medical-device software. The role combines hands-on manual and automated testing, verification and validation, test planning, firmware and communication-software quality, requirements and design reviews, root-cause analysis, risk management, documentation, and audit readiness. The position is suited to an experienced quality engineer comfortable taking ownership of test execution and quality activities.
Highlights
Hands-on quality engineering role focused on medical-device software, with ownership of verification and validation, test automation, quality processes, and regulatory activities. Offers leadership responsibilities and exposure to firmware, communication software, and product development.
Description
🚨 Hiring: Software Development Quality Engineer II
📍 Location: Sylmar, CA
🏢 Workplace: Onsite
💼 Employment Type: W2 Contract/1099 Contract
🏥 Industry: Medical Devices / Healthcare
🎓 Experience: 5+ Years
We are looking for a Software Development Quality Engineer II to support the design and development of new products, with a strong focus on firmware, communication software, software testing, and Verification & Validation (V&V).
🔹 Key Responsibilities
• Plan and execute manual and automated software test plans, procedures, scripts, and reports
• Lead test planning and execution activities
• Perform Design Verification & Validation (V&V) and hands-on testing
• Develop and support test automation
• Participate in software/firmware requirements and design reviews
• Perform root-cause analysis and issue resolution
• Support software risk management and quality activities
• Maintain SOPs, specifications, test procedures, and DHF documentation
• Support audits and regulatory compliance activities
• Drive continuous improvement in software and firmware testing processes
🔹 Required Qualifications
• Bachelor's degree in Engineering or a related technical field, or equivalent experience
• 2–5+ years of software development/embedded systems experience
• 2–5+ years of software testing and Verification/Validation experience
• Programming experience with C, C++, C#, Python, Java, or Visual Studio
• Experience with Git, Jira, Subversion, DOORS, Bugzilla, or similar tools
• Experience with code review/static analysis tools such as Coverity or Parasoft
• Knowledge of V-Model, Agile/Scrum, and iterative SDLC methodologies
• Experience supporting automated test execution
• Knowledge of FDA, GMP, IEEE 1012, and ISO 13485
• Strong communication, collaboration, analytical, and problem-solving skills
⭐ Preferred: Medical device industry experience and ASQ CSQE certification.
📩 Interested candidates, please share your updated resume to mohamedrafi.j@highbrowtechnology.com
