- VTI Life Sciences (Naples, FL)
- …companies in the Life Sciences industry. We are looking for a Process Validation Engineer/Consultant for our Naples, Florida area medical device client ... Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive… more
- Oracle (Tallahassee, FL)
- …long-term technology strategy. You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA ... support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven… more
- Oracle (Tallahassee, FL)
- …is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, ... usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product...(IEC 62366), ensuring requirements map to user needs and validation meets usability and human factors standards. . Lead… more
- Oracle (Tallahassee, FL)
- …is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, ... usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product...(IEC 62366), ensuring requirements map to user needs and validation meets usability and human factors standards. . Lead… more
- Stryker (Orlando, FL)
- …Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) and ... in conjunction with R&D and Quality. + Work on process improvement projects while applying software industry practices, compliance...visualization and monitoring. + Exposure to Software as a Medical Device (SaMD), Software in a … more
- Bausch + Lomb (Clearwater, FL)
- …industry best practices. This includes the development, manufacturing and release of medical device product. KEY ACTIVITIES / RESPONSIBILITIES **Micro lab ... operational excellence and innovation. + 10-15 years of microbiology experience in biopharmaceutical/ medical device industry of which minimum of 5 years is… more
- Cordis (Miami Lakes, FL)
- …candidate has hands-on experience with extrusion process development, optimization, and validation in a regulated medical device environment. **Key ... to join our team. This role will focus on polymer and fluoropolymer extrusion for critical medical device components and catheter shaft assemblies. The ideal… more
- Kelly Services (Jacksonville, FL)
- …regulations, ISO standards, and GMP requirements specific to medical device manufacturing. + **Documentation & Validation ** Generate and maintain ... optimize control systems for advanced automated manufacturing equipment in a regulated medical device environment. You will be instrumental in improving… more
- Cordis (Miami Lakes, FL)
- …coating equipment, and packaging equipment + Oversees equipment qualification, test method validation , process validation , design validation testing, ... focus on hiring and managing a team of development, process , and combination device engineers. This role...product design transfer and commercialization + PMA Experience + Medical device product development and operations experience… more
- GRAIL (Tallahassee, FL)
- …regulatory, development, clinical affairs, quality, or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and ... Demonstrated knowledge of US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in… more
- Cordis (Miami Lakes, FL)
- …Engineering discipline with minimum of 5 years of relevant experience, preferably in a medical device environment. * Proven track record working within ISO 13485 ... improved manufacturing procedures and work instructions. . Plan, write, and execute process and equipment validation protocols (IQ/OQ/PQ). . Investigate and… more
- Terumo Aortic (Sunrise, FL)
- …degree in engineering/science and a minimum of 5 years' experience in the medical device industry or master's degree in engineering/science and a minimum ... of 4 years' experience in the medical device industry or technical degree/certificate with appropriately equivalent technical experience in the medical … more
- Medtronic (Jacksonville, FL)
- …Engineer Experience in electronics and electronic safety testing Medical device experience Experience in software, software validation and software security ... OUs. The campus houses the full spectrum of the medical device innovation cycle - ideation, R&D,...research and development as they apply to product or process quality. **Required Knowledge and Experience:** Requires a Baccalaureate… more
- Ford Motor Company (Tallahassee, FL)
- **In this position ** Electrical systems integration and validation , approve device transmittals, develop vehicle-level logical schematics, conduct ... design/compatibility reviews, support system-level validation /diagnostics, provide technical support for prototype and pre-production builds. **What You'll Do ** *… more
- Fujifilm (Tallahassee, FL)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's… more
- J&J Family of Companies (Jacksonville, FL)
- …and optimize injection molding processes for new and existing products that meets medical device regulatory standards (FDA, ISO 13485). + Create, coordinate, and ... mold design, and injection molding equipment. + Proven experience with process validation (IQ/OQ/PQ), SPC, and root cause analysis (eg, 5 Whys, Fishbone).… more
- Oracle (Tallahassee, FL)
- …and AI-enabled population health platform. As HDI accelerates readiness for MDR ( Medical Device Regulation), AI regulatory requirements, and emerging global ... including: + Cloud security posture analysis + Control architecture validation + Secure-by-design pattern evaluation + AI system risk...Tech)** + Experience with one or more: + MDR ( Medical Device Regulation) + ISO 14971 (risk… more
- General Motors (Tallahassee, FL)
- …the intersection of requirement definition, architecture and system design, integration, and validation across the AV organization. This team ensures a cohesive and ... targets. + Collaborate cross-functionally with software architecture, firmware, hardware, validation , and vehicle integration teams to ensure cohesive system design… more
- Parexel (Tallahassee, FL)
- …dynamic Patient Safety team as a **Senior Physician** where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and ... post-marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance… more
- Edwards Lifesciences (Tallahassee, FL)
- …etc.) required; Architecture certification: TOGAF, ZACHMAN, etc. + Experience (eg medical device , pharmaceuticals, etc.) or in highly regulated environments ... administration, enhancing, implementing and optimizing solutions that improve business process efficiencies and effectiveness. This role has the domain expertise… more