Software Quality Engineer

Role & responsibilities

• Design, develop, and optimize high-performance SAMD applications using SIMD for real-time.
• Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements.
• Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables.
• Participate in internal audits, regulatory submissions, and post-market surveillance for software updates.
• Support validation and verification activities, including unit testing, integration testing, and system testing under regulatory frameworks.
• Deep understanding of IEC 62304, ISO 14971, ISO 13485, IEC 82304 guidelines, and Usability and FDA (Pre- and Post-market) Cybersecurity Guidelines.
• Prior experience with FDA 510(k) or PMA/De-Nova submissions and regulatory submissions.
• Maintaining a complete track record of all the software changes and documents.

Education

• Bachelors or masters degree in software engineering, Computer Science, Biomedical Engineering, or related field.
• Experience: Minimum 25 years of experience in medical device software QA/RA. Hands-on experience with regulatory submissions (FDA, EU MDR).