- Oracle (Austin, TX)
- …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 (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 ... 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 (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 ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Caris Life Sciences (Irving, TX)
- …(CDx) or NGS (Next Gen Sequencing) is a plus. + Working knowledge or familiarity with medical device software (IEC 62304) is a plus. **Physical Demands** + ... This role will be quality the subject matter expert for software development of medical device and computerized systems. **Job Responsibilities** + Authors… more
- Oracle (Austin, TX)
- …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 (Austin, TX)
- …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 (San Antonio, TX)
- …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
- Oracle (Austin, TX)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with ... applications used in clinical operation, clinical information systems, and clinical decision support ( medical device and non- medical Device ). You will… more
- Oracle (Austin, TX)
- … Device Integration team is comprised of four main products including Bedside Medical Device Integration (BMDI), Laboratory Medical Device Integration ... consulting implementation services to clients throughout North America for our medical device connectivity products. These services include the integrated… more
- Mallinckrodt Pharmaceuticals (Dallas, TX)
- Job Title Medical Device Service Technician Requisition JR000015587 Medical Device Service Technician (Open) Location Dallas, TX Additional Locations Job ... Description Summary Job Description Summary Responsible for medical device maintenance and service according to company established guidelines and policies. This… more