- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus' medical software development environment and quality system + Contributes ... into the back-end of our next generation of our medical software + Tests and fine tunes... development environments (VisualStudio, VisualStudio Code) and GIT. + Medical device or life sciences experience are… more
- Oracle (Harrisburg, PA)
- …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 (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 ... 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 (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 ... 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 (Harrisburg, PA)
- …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
- Jabil (West Chester, PA)
- …teams. + Skilled in using PC-based systems including Microsoft Office and quality management software . Preferred Qualifications: + Experience with inspection ... globe. How will you make an impact? As a Quality Engineer, you will support key quality ...systems. + Assist in validation activities for processes, equipment, software , and computerized systems. + Prepare and maintain clear… more
- Oracle (Harrisburg, PA)
- …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
- Philips (Reedsville, PA)
- **System Integration Engineer - Medical Device Hardware (Reedsville, PA)** As a production focused member of the team, you will contribute to the development and ... Engineering and product integration and testing in FDA Regulated (ISO 13485) Medical Device product development (other highly regulated environments could be… more
- Globus Medical, Inc. (Audubon, PA)
- …the development of integration/unit tests and documentation. + Demonstrate a passion for medical devices and product development, software craftsmanship, and ... and a good understanding of the development process for medical devices together with clinical knowledge of...degree with 5-7 years of experience. + Experience in Medical Device development + Experience in … more
- Globus Medical, Inc. (Audubon, PA)
- …testing, and systematic product development. **Essential Functions:** + Design, build, and test software for connected medical devices , ensuring adherence to ... mechanical, and software engineers to integrate system software into market-ready medical device ...time **Preferred Knowledge, Experience, and Skills:** + Experience developing software /firmware for medical devices , wearables,… more