Software Engineer Job at Skills Alliance, San Diego, CA

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  • Skills Alliance
  • San Diego, CA

Job Description

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.

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