5 of 5 Remote IEC 62304 Jobs

develop safe and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross More ❯

develop safe and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO 13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional More ❯

bare-metal programming Hardware/software integration and debugging Full life cycle product/software development Agile/Scrum experience Experience in regulated industries (IEC 62304, DO-178) ADDITIONAL DUTIES Assist with project estimation and planning Participate in continuous improvement Occasional travel may be required (estimated Why you More ❯

collaborate with R&D, engineering, and security teams for issue resolution. • Document testing methodologies, defects, and performance metrics in compliance with FDA, ISO 13485, IEC 62304, and HIPAA regulations. • Support root cause analysis (RCA) and corrective/preventive actions (CAPA) based on test findings. Collaboration & Continuous Improvement • Work … Appium, Cypress). • Familiarity with network protocols, security testing, and performance benchmarking. • Understanding of FDA 21 CFR Part 820, ISO 14971 (Risk Management), and IEC 60601 standards. Preferred: • Experience with cloud-based medical device testing (AWS, Azure, IoT platforms). • Knowledge of cybersecurity frameworks (NIST, OWASP, FIPS More ❯

and ML frameworks such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data More ❯