- Abbott (Pleasanton, CA)
- …requirements for US, EU (EU MDR), and other international geographies. + Experience with medical device software requirements and software regulations. + ... US device regulations and/or experience with EU and other international medical device regulations and submissions. + Ability to work in a highly matrixed… more
- GE HealthCare (Bellevue, WA)
- … development and familiarity with Software Development Lifecycle (SDLC) in medical device or healthcare software development environment. + Experience ... experience is preferred. + Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but… more
- Medtronic (Lafayette, CO)
- …in partnership with our project managers as a subject matter expert with our suite of medical device and software offerings * Develop a deep understanding of ... set up, configuration and deployment of both hardware and software -based products. This is both a challenging and rewarding...opportunity to demonstrate both technical proficiency and hands on medical device set up and deployment of… more
- J&J Family of Companies (Cincinnati, OH)
- …and specifications per design control processes and conform to Industry Standards for Medical Device Software (IEC 62304) **Qualifications / Requirements:** ... into the design and development of product hardware and software for use in cutting edge medical ...and software for use in cutting edge medical devices and associated capital equipment **You will be… more
- Radformation (New York, NY)
- …engineer experience across multiple products * Familiarity with FDA Class IIa+ regulated medical device software * Building automation frameworks and ... in a regulated software environment. Many of our products are SaMD medical devices, so you will ensure that testing provides products that are high quality,… more
- GE HealthCare (Wauwatosa, WI)
- …healthcare industry + Knowledge of ultrasound or demonstrated experience with development of medical device software + Experience with cyber security ... communicate and track product vulnerabilities. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives… more
- Danaher Corporation (Washington, DC)
- …+ Experience with regulatory processes, especially for medical devices and AI/ML-based software as a medical device (SaMD). + Familiarity with quality ... System which makes everything possible. The Sr. AI Engineer, Device Intelligence will be a key member of the...spanning multi-quarter timelines. + Drive innovation in the AI software stack, focusing on maximizing value extraction from instruments… more
- Abbott (Alameda, CA)
- …Backend, Cloud/Platform, Security, Product, and Compliance to remove obstacles in a regulated, medical device software environment. + Lead and mentor the ... model data interfaces, real-time inference). + Demonstrated success in regulated environments; understands medical device software realities and how to stay… more
- Danaher Corporation (Washington, DC)
- …+ Experience with regulatory processes, especially for medical devices and AI/ML-based software as a medical device (SaMD). + Familiarity with quality ... about the Danaher Business System which makes everything possible. The AI Evaluation Engineer, Device Intelligence will be a key member of the AI Product and Imaging… more
- Terumo Neuro (Aliso Viejo, CA)
- …methods, including principles of formal computer software validation (CSV). Knowledge of medical device software regulations. 7. Strong ability to design ... and maintenance of enterprise systems, off-the-shelf applications, and custom/low-code software development. + Oversee design, implementation, and optimization of… more