Staff Software Engineer, Medical Devices & Healthcare Integration — Boston

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 into integrated delivery networks (IDNs), hospital systems, academic medical centers, or reference laboratories.  • Experience working directly with Epic integration teams, hospital interoperability groups, laboratory informatics organizations, or healthcare IT departments.  • Experience with embedded Linux, Go, Rust, C, or C++.  • Experience with machine learning applications in diagnostics, clinical decision support, pathology, imaging, or laboratory analytics.  Non-Technical Requirements    • Willingness to live in Massachusetts and work onsite as required.   • Ability to thrive in multidisciplinary environments and collaborate effectively with engineers, scientists, clinicians, and healthcare stakeholders.   • Strong problem-solving, critical-thinking, and communication skills.   • Ability to work independently while providing clear status updates and realistic estimates.   • Commitment to continuous learning and improving both technical capabilities and team outcomes.   • Passion for developing technologies that improve healthcare, diagnostics, and patient outcomes.   For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export  licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls.  As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process. Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group. EEO is the Law: Notice of Applicant Rights Under the Law . Job Req Type: Experienced            Required Travel: Yes, 10% of the time            Shift Type: 1st Shift/Days The expected wage range for a new hire into this position is $134,644 to $201,966. • Actual wage offered may vary depending on work location , experience, education, training, external market data, internal pay equity, or other bona fide factors. • This position qualifies for a discretionary performance-based bonus which is based on personal and company factors. • This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time , and other benefits.