Software Engineer

Hogan Lovells Cadwalader · Washington DC · commensurate with experience We are seeking a skilled Software Engineer to own and support software and cybersecurity documentation for FDA regulatory submissions for our software and Software as a Medical Device (SaMD) products. Key Responsibilities Author, review, and maintain software description and software documentation sections of FDA regulatory submissions, including 510(k), PMA supplement, and De Novo filings Develop and update software-related submission content such as software level of concern analyses, software requirements specifications (SRS), architecture and design descriptions, traceability matrices, and verification and validation summaries Review and prepare cybersecurity sections of submissions, including threat modeling documentation, cybersecurity risk assessments, Software Bill of Materials (SBOM), and vulnerability/patch management plans Serve as technical subject matter expert (SME) for software-related questions from regulatory affairs, quality, and clinical teams Respond to FDA Additional Information (AI) requests and deficiency questions related to software and cybersecurity content Stay current with FDA guidance documents on software, SaMD, cybersecurity, and AI/ML-enabled devices Quality System Support Support Quality Management System (QMS) activities related to software development, including design controls, software development lifecycle (SDLC) documentation, and design history file (DHF) maintenance Contribute to development and maintenance of software-related standard operating procedures (SOPs), work instructions, and templates within the QMS Participate in internal audits and inspection readiness activities as the software engineering representative Assist with software-related corrective and preventive actions (CAPAs), non-conformance investigations, and root cause analyses Support complaint handling and post-market activities that require software engineering input or analysis General Maintain working knowledge of applicable regulations, standards, and guidance documents relevant to medical device software Act as a go-to technical resource for internal teams, answering questions about software architecture, design decisions, testing strategies, and cybersecurity controls Support cross-functional teams in translating regulatory requirements into actionable engineering tasks within agile and iterative development workflows Qualifications Bachelor's degree in software engineering, computer science, computer engineering, biomedical engineering, or a related technical field 3–7 years of experience as a software engineer or software quality engineer in a regulated healthcare, life sciences, or medical device environment Hands-on experience writing or reviewing software and cybersecurity sections of FDA premarket submissions Solid understanding of software development lifecycle (SDLC) for medical devices, including IEC 62304 lifecycle processes, risk management per ISO 14971, and design control requirements under 21 CFR Part 820 Demonstrated experience with cybersecurity documentation for FDA submissions Experience supporting Quality Management System (QMS) activities Strong technical writing skills with the ability to produce clear, accurate, and regulator-ready software documentation Preferred Qualifications Experience with cloud-hosted, AI/ML-enabled, or continuously learning software in a regulated medical device environment Familiarity with FDA's Digital Health Center of Excellence (DHCoE) policies and Computer Software Assurance (CSA) guidance Experience with EU MDR/IVDR technical documentation for software products Knowledge of cybersecurity frameworks applicable to medical devices Familiarity with software composition analysis (SCA) tools, static/dynamic analysis tools, and penetration testing Certified Software Quality Engineer (CSQE) or similar quality/engineering certification