3 of 3 Remote Contract ISO 13485 Jobs

technical strategy. Develop novel approaches to overcome product development challenges. Maintain quality records across chemistry, consumables, and instrument activities. Ensure documentation complies with ISO 13485 requirements in collaboration with Quality. About You You ll bring a strong background in systems engineering within IVD, diagnostics or closely regulated medical … Excellent communication, documentation, and cross-functional collaboration skills. Strong root-cause analysis skills across electro-mechanical and instrument systems. Experience applying standards such as ISO 13485, IEC 62304, 21 CFR 820, IVDR, IEC 62366. Familiarity with ISO 14971 risk management (FMEA, FTA etc.). Broad engineering understanding ...

testing using automation and static code analysis tools. Debug hardware using oscilloscopes and logic analyzers. Ensure compliance with IEC 62304 , FDA , EU MDR , and ISO 13485 throughout development. Collaborate with multi-disciplinary teams in an Agile environment. Essential Skills Embedded firmware development experience (7+ years) with C/… EEPROM, micro-SD). Knowledge of secure bootloaders , firmware updates , and software architecture principles. Familiarity with IEC 62304 , FDA , EU MDR , and ISO 13485 compliance requirements. Ability to debug hardware using oscilloscopes and logic analyzers. Desirable Skills Experience with CI/CD pipelines , configuration management, and cloud-based ...

testing using automation and static code analysis tools. Debug hardware using oscilloscopes and logic analyzers. Ensure compliance with IEC 62304 , FDA , EU MDR , and ISO 13485 throughout development. Collaborate with multi-disciplinary teams in an Agile environment. Essential Skills Embedded firmware development experience (7+ years) with C/… EEPROM, micro-SD). Knowledge of secure bootloaders , firmware updates , and software architecture principles. Familiarity with IEC 62304 , FDA , EU MDR , and ISO 13485 compliance requirements. Ability to debug hardware using oscilloscopes and logic analyzers. Desirable Skills Experience with CI/CD pipelines , configuration management, and cloud-based ...