Skills Alliance
Overview
Direct message the job poster from Skills Alliance. 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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Direct message the job poster from Skills Alliance. 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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