- Oracle (Harrisburg, PA)
- …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 (Harrisburg, PA)
- …. 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 (Harrisburg, PA)
- …. 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
- Globus Medical, Inc. (Audubon, PA)
- …to the latest tools and methodologies in C++ development, robotics integration, and medical device software , with opportunities for continuous learning and ... and components for medical or robotic applications + Familiarity with medical device development, including regulatory and safety considerations, is highly… more
- Insight Global (Indiana, PA)
- …the technical direction of the Cevego software development team globally. This role focuses on Software in a Medical Device (SiMD), Software as a ... equivalent technology discipline (preferred) * Experience: ○ Significant experience in medical device and embedded software development in a regulated… more
- Oracle (Harrisburg, PA)
- …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
- Bayer (Rose Valley, PA)
- …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 (Harrisburg, PA)
- …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 (Harrisburg, PA)
- … 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
- Bayer (Indianola, PA)
- …of product requirement and software requirement to design and develop medical device and improve customer value; + Deliver high-quality and scalable ... FDA Cybersecurity in Medical Devices; + IEC 62304 - Software in a Medical Device ; + Effectively collaborates within cross-functional teams across… more