Software Quality Assurance Engineer

Company Culture

My client fosters a diverse, innovative, and collaborative work environment. They are a global leader in the Medical Device industry, and you'll have the opportunity to work with high-performing teams on projects that make a real difference.

They offer ongoing support and access to the latest tools and training to help you advance your career.

About the Role

This hybrid position is based in Valencia, CA, with an expectation of 3 days on-site per week. You'll join a team of talented professionals as a Software Quality Assurance Engineer II, playing a key role in the development of Neuromodulation Software / Firmware products.

Your responsibilities will span the entire product lifecycle, from design to launch and beyond.

My Client is a leader in Neuromodulation Technology

My client develops implantable medical devices that help patients manage chronic pain and neurological conditions. In this role, you'll be contributing to this critical work.

Responsibilities

• Collaborate effectively within a team of Software Quality Assurance Engineers.
• Ensure the quality of software systems throughout the development lifecycle in a highly regulated environment for Active Implantable Medical Devices.
• Validate product software and firmware requirements, ensuring they meet security and compliance standards.
• Support all aspects of software development, testing, and validation for Neuromodulation product lines.
• Participate in creating and executing Design Validation Plans, Protocols, and Reports to perform system-level testing and report any issues.
• Review design, development, and testing activities for Neuromodulation software and firmware.
• Review and approve documentation related to user requirements, hazard analysis, security risk assessments, usability, and more.
• Contribute to Automated Test Equipment validation activities.
• Support Software-related Corrective and Preventive Action (CAPA) processes.
• Participate in Design Validation activities, including reviewing various aspects of the design process, testing activities, risk management, and regulatory compliance.

Qualifications

• Bachelor's degree in Computer Science, Software / Electrical Engineering, Biomedical Engineering, or a related field.
• 2+ years of relevant work experience.
• Solid understanding of testing processes and methodologies.
• Experience with manual system-level testing in a regulated environment.
• Knowledge of Software Development Life Cycle (SDLC) processes as per IEC 62304.
• Experience with programming languages (C#, C++, Swift, Node.js, Java / JavaScript, etc.)

Preferred Qualifications

• Master's degree in Computer Science, Software / Electrical Engineering, or a related field.
• Excellent communication (verbal and written) and organizational skills.
• Strong teamwork abilities with a positive attitude. Ability to manage multiple tasks and collaborate effectively with various departments (R&D, Marketing, Manufacturing, Quality & Regulatory, Clinical, Project Management, etc.).
• Detail-oriented with a passion for quality.
• Experience in the medical device industry or a highly regulated environment (a plus).
• Basic understanding of Neuromodulation principles.
• Familiarity with CAPA, Complaint Handling, and External Audits (a plus).
• Knowledge of Risk Management principles as per ISO 14971 (a plus).
• Understanding of Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance, and 81001-5-1 (a plus).
• Knowledge of Bluetooth technology (a plus).
• Experience with mobile application development (a plus).
• Familiarity with HIPAA and GDPR compliance practices (a plus).
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) (a plus).
29 days ago