- Oracle (Olympia, WA)
- …and support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven ... **Responsibilities:** As a Principal Member of Technical Staff for Medical Device Software , your key responsibilities include: + Architectural… more
- Oracle (Olympia, WA)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Oracle (Olympia, WA)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Fujifilm (Bothell, WA)
- …engineering practices and processesfor medical devices + Demonstrated experience developing medical device software compliant with IEC 62304 + Experience ... the resolutions meetperformance requirements andcustomer expectations. + Producesoftwarearchitecturedocumentationincompliance with medical device development standards. + Stay abreast… more
- Stryker (Redmond, WA)
- …code/vulnerability analysis and bug tracking tools. + Create efficient deployment processes for medical device software and ensure compliance with industry ... within the SDLC. + Familiar with regulatory and compliance standards relevant to medical device software , including IEC 62304, ISO 13485, and the FDA's… more
- Oracle (Olympia, WA)
- …ensure our software development practices meet the expectations for medical device safety, risk management, usability, security, and post-market ... + Drive cross-functional alignment on regulatory, quality, and engineering needs for medical device -class software solutions. + Establish program roadmaps,… more
- Oracle (Olympia, WA)
- …Minimum 7 years' experience in clinical leadership roles within medical device , digital health, or regulated healthcare software sectors. . Extensive ... products newly classified under stricter EU medical device rules. . Knowledge of software development...medical device rules. . Knowledge of software development processes (including agile and/or AI-enabled methodologies) and… more
- Bayer (Warden, WA)
- …imaging, or related CT modalities. **PREFERRED QUALIFICATIONS** + Knowledge of Bayer's medical device , software , contrast media, and service portfolio; ... (CT) and cardiovascular (CV) portfolio, including injectors, contrast media, and related software and workflow solutions. They generate demand for the CT / CV… more
- Amazon (Seattle, WA)
- …Strategic Design Leadership: - Own UX vision and strategy across multiple device software services, ensuring alignment with Amazon's brand identity and ... Guide the end-to-end design process from concept to implementation across complex device software services - Establish best practices for information… more
- Amazon (Redmond, WA)
- …of satellite communications technology to make global connectivity a reality. As a Device Software Development Engineer on the Amazon Leo for Government (ALG)'s ... scalable solutions for custom satellite and ground applications. ALG Device Software focuses on embedded software...compensation package, in addition to a full range of medical , financial, and/or other benefits. For more information, please… more