- Oracle (Austin, TX)
- …compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical device software standards including IEC 62304 ( software ... software architecture and compliance framework for regulated medical devices . This role bridges product development,...of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and… more
- Oracle (Austin, TX)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical … more
- Oracle (Austin, TX)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical … more
- Mallinckrodt Pharmaceuticals (Dallas, TX)
- …warehouse, distribution and delivery. Essential Functions + Performs required medical device service and maintenance in compliance with quality systems and ... Job Title Medical Device Service Technician Requisition JR000015587...school diploma or equivalent with certifications or coursework in medical devices (electronics) with 5+ years of… more
- Oracle (Austin, TX)
- …as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU ... success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with… more
- Oracle (Austin, TX)
- …to lead and mature our quality systems and regulatory readiness for AI-enabled Software as a Medical Device (SaMD) and digital health solutions. This ... role sits within HDI's **Regulatory & Medical Device organization.** You will serve as...tactically. Preferred Experience + Background in digital health, AI/ML medical software , or imaging platforms. + Experience… more
- Cisco (Austin, TX)
- **Meet the Team** The Cisco Component Quality and Technology team provides outstanding customer value through technical innovation and quality solutions. We are ... technical expert in semiconductor components and their applications in high-speed systems. Devices we work with include ASICs, NPUs, CPUs, Ethernet switches, FPGAs,… more
- Caris Life Sciences (Irving, TX)
- …outcomes. This role will be quality the subject matter expert for software development of medical device and computerized systems. **Job ... quality leader to support long-term software quality strategy for software medical ...is a plus. + Working knowledge or familiarity with medical device software (IEC 62304)… more
- Zimmer Biomet (Austin, TX)
- …directly in the Medical Device field, testing specifcally for automated medical devices is a plus **Your Background** + Bachelor's degree in computer ... innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's...and recognised. **What You Can Expect** As a **Senior Software Quality Engineer** you will be responsible… more
- Cisco (Richardson, TX)
- …+ 8+ years of experience in designing, developing, and testing enterprise-class video/audio device software and a Bachelor's or Master's Degree in Computer ... room devices . + Drives innovation to improve wireless connectivity, device interoperability, and user experience in hybrid workspaces. + Recommends improvements… more
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