for humanity. Learn more at https://www.jnj.com Job Function: R&D Operations Job Sub Function: Clinical Trial Project... in accordance with SOPs, other procedural documents and applicable regulations. Organizes and ensures IEC/HA approvals...
standards (e.g. NIST, ISO/IEC 27001, MITRE security framework, etc.) is highly desired. Key Responsibilities: In general..., including NIST, IEC 60601-4-5, and IEC 81001-5-1. Conduct regular assessments and collaborate with development teams to enforce...
standards (e.g., IEC 62304). Conduct code reviews, unit testing, and debugging to ensure software reliability and performance... experience with C and C++. Developed and reviewed documentation according to medical device regulatory standards (e.g., IEC...
with standardized testing and R&D projects Maintain test equipment and test facilities and oversee the equipment calibration process... Experience in a fast-paced test environment with flight hardware Able to support R&D efforts in addition to standardized testing...
of complex systems;strong troubleshooting. Proficiency in IEC PLC languages. HMI experience (FactoryTalk View preferred..., Siemens, Panasonic, Schneider Electric, B&R Industrial Automation, Sigmatek) Industrial Robot...
with standardized testing and R&D projects Maintain test equipment and test facilities and oversee the equipment calibration process... Experience in a fast-paced test environment with flight hardware Able to support R&D efforts in addition to standardized testing...
Job Category: Engineering Job Description: JOB SUMMARY: The R+D Firmware Engineering Testing Manager leads a team... verification and validation activities comply with FDA 21 CFR Part 820, ISO 13485, and IEC 62304. Collaborates with Systems...
in accordance with IEC 62366 and FDA Human Factors guidance. Identify user profiles, tasks, critical use scenarios, usability risks...-Functional Collaboration & Influence: Champion usability, safety, accessibility, and quality across R&D, Engineering, UX...
, while effectively partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus, resolve disagreements... of IEC 62304 (Medical device software – software life cycle processes). Experience with medical device systems...
vendors). Oversee testing (stability/safety/compatibility), regulatory and compliance (including IEC/FDA considerations... architecture, and unit-economics trade-offs. Maintain strong relationships with R&D, QA/Regulatory, and Packaging...