Software Engineer Job at Skills Alliance in San Diego

Software Engineer – Medical Devices

Please note: This role requires prior experience in the medical device industry. Applications without this background will not be considered.

Responsibilities

• Design, develop, and maintain software in compliance with FDA QSR, EU MDR, and IEC 62304.
• Collaborate with cross-functional teams (QA/RA, hardware, clinical) to ensure safe, effective, and reliable products.
• Support documentation, testing, and risk management in line with ISO 14971, IEC 62366.
• Contribute to product innovation while maintaining strict regulatory compliance.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
• Proven software engineering experience in the medical device industry (required).
• Solid knowledge of medical device regulations (FDA QSR, EU MDR) and related standards such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, and TIR 57.
• Strong programming skills (C++, C#, or Python) in embedded or cloud-based medical platforms.
• Experience working in regulated environments with design controls, verification, and validation.