Staff Software Engineer, Medical Devices & Healthcare Integration

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com  and on LinkedIn and X . A rapid research and development group within Analog Devices, Inc. is seeking a collaborative, self-driven Software Engineer to develop next-generation medical devices, diagnostic platforms, and clinical laboratory systems.  The ideal candidate has hands-on experience developing software for regulated medical devices and diagnostic instruments that integrate with enterprise healthcare environments, including Laboratory Information Systems (LIS/LIMS), Electronic Health Records (EHR/EMR), PACS/VNA imaging systems, and clinical decision-support workflows.  This individual will partner closely with biomedical engineers, clinicians, scientists, and healthcare stakeholders to translate innovative concepts into production-ready medical technologies. Successful candidates will have experience delivering software that supports clinical workflows, laboratory operations, diagnostic testing, healthcare interoperability, and regulatory compliance.  Experience bringing connected medical devices from prototype through verification, validation, regulatory submission support, and commercial deployment is highly valued.  Key Responsibilities    Design, develop, and maintain software for regulated medical devices, in-vitro diagnostic (IVD) systems, laboratory instrumentation, and connected healthcare platforms.   Develop and support integrations between medical devices and healthcare enterprise systems including LIS/LIMS, EHR/EMR, PACS/VNA, middleware, and laboratory automation platforms.  Implement healthcare interoperability standards including HL7 v2.x, FHIR, DICOM, ASTM, and IHE profiles to enable bidirectional clinical data exchange.  Build software supporting core clinical and laboratory workflows such as patient demographics, order management, specimen tracking, instrument connectivity, result reporting, quality control, and clinical documentation.  Collaborate with clinicians, laboratory directors, pathologists, biomedical engineers, and healthcare IT teams to define requirements and ensure successful deployment within hospital and laboratory environments.  Contribute to system architecture across embedded software, instrument control, cloud infrastructure, middleware, and clinical-facing applications.  Develop secure APIs, cloud services, and enterprise integration solutions that support healthcare and diagnostic workflows.  Implement and optimize software for real-time control systems, sensor integration, data acquisition, signal processing, analytics, and monitoring applications.  Support software lifecycle activities including requirements management, risk analysis, design reviews, verification, validation, traceability, and change control within regulated environments.  Technical Requirements    Medical Device & Healthcare Software Experience   Strong candidates will possess many of the following qualifications:  5+ years developing software for medical devices, diagnostic instruments, laboratory systems, healthcare technology platforms, or other regulated healthcare products.  Demonstrated experience deploying production systems within hospitals, clinical laboratories, physician practices, reference laboratories, or healthcare networks.  Hands-on experience integrating medical devices or diagnostic platforms with:  Epic (including Beaker)  Oracle Cerner  MEDITECH  Mirth Connect / NextGen Connect  Sunquest  SCC Soft  Orchard Software  Labcorp and Quest laboratory interfaces  PACS/VNA environments  Experience implementing bidirectional LIS/LIMS workflows including:  Order ingestion  Specimen management  Instrument communication  Results transmission  Clinical reporting  Quality control workflows  Strong understanding of healthcare interoperability standards including HL7 v2.x, FHIR, DICOM, ASTM, and healthcare integration architectures.  Experience collaborating with hospital IT, healthcare interoperability teams, laboratory informatics groups, or clinical operations teams.  Software Development   Expert-level proficiency in Python and modern development frameworks such as FastAPI, Pydantic, SQLModel, PyTorch, or comparable technologies.  Experience developing production software across Linux-based embedded platforms, Windows, and macOS environments.  Strong understanding of instrumentation software, device communications, sensor-driven systems, embedded interfaces, and hardware/software integration.  Experience designing scalable service-oriented architectures, APIs, and secure healthcare data platforms.  Regulatory & Quality Systems   Experience developing software under FDA-regulated medical device development processes.  Working knowledge of:  IEC 62304  ISO 13485  ISO 14971  FDA Design Controls  Software Verification & Validation (V&V)  Cybersecurity requirements for medical devices  Software as a Medical Device (SaMD)  Experience creating and maintaining software lifecycle documentation including requirements, risk assessments, traceability matrices, test protocols, and validation reports.  Preferred Qualifications    Experience developing commercial medical devices, in-vitro diagnostics (IVD), digital pathology systems, imaging platforms, or laboratory automation products.  Experience supporting FDA 510(k), PMA, CE Mark, or other regulatory submissions.  Experience deploying solutions in