- GRAIL (Tallahassee, FL)
- …position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual ... 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory… more
- Stryker (Orlando, FL)
- …to support our Medical's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on ... Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in...62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device … more
- Cleveland Clinic (Weston, FL)
- …and without magnet application (pacemaker only). + Perform interrogation of the patient's device with the programmer that is appropriate for their device , ... the pacemaker lead(s) to determine optimal settings for the device . + Determine underlying rhythm and sensing function, if...and provide booklets for patient education. + Note any device and lead alerts that are received from any… more
- J&J Family of Companies (Tampa, FL)
- …portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary ... Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs.… more
- Medtronic (Jacksonville, FL)
- …integration and compliance. + Develop and review documentation according to medical device regulatory standards (eg, IEC 62304). + Conduct code reviews, unit ... with C and C++. + Developed and reviewed documentation according to medical device regulatory standards (eg, IEC 62304). + Proven track record of leading software… more
- Lockheed Martin (Orlando, FL)
- …and Senior Officer formal courses\. * Provide academic and pilot training device instruction, adhering to published training and readiness standards\. * Instruct ... syllabi, ensuring 100% accuracy\. * Assist students and conduct aircrew training device missions as needed\. * Maintain F\-35 platform, tactics, and weapons system… more
- Philips (Orlando, FL)
- …of 5+ years' experience in Quality Engineering within FDA regulated medical device environments, with proven expertise in Corrective and Preventive Actions (CAPAs) ... data/trend. Analysis. + You have detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and… more
- Kelly Services (Jacksonville, FL)
- …systems for advanced automated manufacturing equipment in a regulated medical device environment. You will be instrumental in improving equipment performance, ... FDA regulations, ISO standards, and GMP requirements specific to medical device manufacturing. + **Documentation & Validation** Generate and maintain comprehensive… more
- RTX Corporation (Largo, FL)
- …and/or FPGA architectures based on high level requirements * Target device trade studies, recommendations, and selection * Generate firmware requirements based ... benches to verify/test the HDL based design * Generate constraints for target device * Create scripts to automate build, integration, and test activities * Verify… more
- BJs Wholesale Club (Cutler Ridge, FL)
- …fast, courteous, and friendly manner by pulling merchandise from a pick list/(RF) device , moving merchandise from sales floor to staging area. + Update merchandise ... with product placement and staging areas. + Utilizes a handheld scanner device (RF) device to pick orders from the sales floor. Uses handheld scanner … more