Skills/Knowledge: Knowledge about applicable standards and regulations related with SW development for Health and/or Medical Device. (ISO 13485, ISO 14971, IEC62304, IEC 82304, ISO 62366, cybersecurity) Familiar with medical device regulations (MDR/IVDR, FDA, etc) Skills & Capabilities: This position has a 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 IEC62304, 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 IEC62304, ISO 14971, IEC 62366, ISO 13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional More ❯
with medical device international regulations and related standards (ISO 13485, ISO 14971, ). Knowledge and experience working in Medical device software life cycle process (IEC62304) Desirable: Knowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA ) Internal auditor qualification for management systems or knowledge 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 IEC62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data More ❯
