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 ❯
LDAP/NIS), authentication protocols (such as Okta, OAuth, OpenID, etc.) is desired. Experience with software development methodologies such as Agile, SDLC as per IEC62304 is desired. Experience with end-to-end DevOps (from requirements to implementation to production to operations) tools such as Azure DevOps, GitHub, etc. is desired. 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 ❯
for medical device software Collaborate with cross-functional teams, including R&D, product management, and QA Ensure software meets regulatory standards (e.g., ISO 13485, IEC62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous improvement initiatives More ❯
where everyone can thrive at work and beyond. Responsibilities Ensure compliance with regulations governing Software Medical Devices including ISO 13485, ISO 27001, and ISO 62304, as well as support for the Quality Management System (QMS) Author technical documentation, and designs and implements Medical Device validation protocols for Software focused More ❯