- 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)
- …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
- Cognizant (Harrisburg, PA)
- …**Role Summary** This role owns the end-to-end lifecycle of connected devices across multi-site retail, consumer goods, and food manufacturing environments. ... You will serve as the technical authority for: + POS and store devices + HVAC and refrigeration racks/case controllers + Networking (including SD-WAN) + Energy… 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
- 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
- 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)
- … is looking for an Associate Software Engineer who is passionate about medical device development. You will be part of a pluri-disciplinary development team ... aspects of software modules or components for medical devices + Deploying, maintaining and updating...experience or be willing to learn the following: + Medical device or life science experiences are… more
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