Medical Device & Technology, Software Engineer

Hogan Lovells•Washington, DC

1d•Onsite

About The Position

Hogan Lovells Cadwalader is seeking a hands-on Software Engineer for its Washington, D.C. office to own and support software and cybersecurity documentation for FDA regulatory submissions covering software and Software as a Medical Device (SaMD) products. The role focuses on authoring, reviewing, and maintaining software-specific submission content, supporting cybersecurity documentation, answering technical questions from cross-functional teams, and contributing to Quality Management System (QMS) activities. The ideal candidate has direct experience in a regulated healthcare or life sciences environment and understands FDA expectations for software documentation. The engineer will prepare and maintain software sections for 510(k), PMA supplement, and De Novo filings; develop documentation such as software requirements, architecture and design descriptions, traceability matrices, and verification and validation summaries; and prepare cybersecurity materials including threat models, risk assessments, SBOMs, and vulnerability and patch management plans. The position also supports QMS processes, audits, inspection readiness, CAPAs, investigations, complaint handling, and post-market activities. The engineer serves as a technical resource for regulatory, quality, and clinical stakeholders and helps translate regulatory requirements into engineering work.

Requirements

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, including 510(k), De Novo, or PMA supplements.
Solid understanding of medical device software SDLC processes, including IEC 62304, ISO 14971 risk management, and design controls under 21 CFR Part 820.
Demonstrated experience with FDA submission cybersecurity documentation, including threat modeling, SBOM preparation, and vulnerability management.
Experience supporting QMS activities, including design controls, DHF documentation, CAPAs, and internal audits.
Strong technical writing skills and the ability to produce clear, accurate, regulator-ready software documentation.
Ability to serve as a technical resource and answer software and cybersecurity questions from regulatory, quality, and clinical stakeholders.
Proficiency in modern software development practices, such as version control, CI/CD, and agile methodologies, in a regulated environment.

Nice To Haves

Advanced degree in a relevant technical field.
Experience with cloud-hosted, AI/ML-enabled, or continuously learning software in a regulated medical device environment.
Familiarity with FDA Digital Health Center of Excellence policies and Computer Software Assurance guidance.
Experience with EU MDR/IVDR technical documentation for software products.
Knowledge of medical device cybersecurity frameworks such as IEC 62443 and the NIST Cybersecurity Framework.
Familiarity with software composition analysis tools, static and dynamic analysis tools, and penetration testing.
Certified Software Quality Engineer (CSQE) certification or a similar quality or engineering certification.

Responsibilities

Author, review, and maintain software descriptions and software documentation for FDA regulatory submissions, including 510(k), PMA supplement, and De Novo filings.
Develop and update software submission content, including software level of concern analyses, software requirements specifications, architecture and design descriptions, traceability matrices, and verification and validation summaries.
Prepare and review submission cybersecurity content, including threat modeling documentation, cybersecurity risk assessments, Software Bill of Materials (SBOM), and vulnerability and patch management plans.
Serve as the technical subject matter expert for software-related questions from regulatory affairs, quality, and clinical teams during submission preparation.
Respond to FDA Additional Information requests and deficiency questions relating to software and cybersecurity content.
Track relevant FDA guidance on software, SaMD, cybersecurity, and AI/ML-enabled devices and ensure submission content reflects current expectations.
Support QMS activities related to software development, including design controls, SDLC documentation, and design history file maintenance.
Contribute to software-related SOPs, work instructions, and templates within the QMS.
Participate in internal audits and inspection readiness as the software engineering representative, preparing and organizing software SDLC records, test documentation, and CAPA evidence.
Assist with software-related CAPAs, non-conformance investigations, and root cause analyses.
Support complaint handling and post-market activities requiring software engineering input or analysis.
Maintain working knowledge of applicable regulations, standards, and guidance for medical device software, including 21 CFR Part 820, IEC 62304, IEC 62443, ISO 14971, and FDA guidance.
Act as a technical resource for internal teams on software architecture, design decisions, testing strategies, and cybersecurity controls as they relate to regulatory requirements.
Help cross-functional teams translate regulatory requirements into actionable engineering tasks within agile and iterative development workflows.