Medical Device & Technology, Software Engineer
Hogan Lovells2 days ago
Washington, DC, USAMid Level / Senior
Responsibilities
- Author, review, and maintain software sections of FDA 510(k), PMA supplement, and De Novo submissions.
- Prepare software requirements, architecture and design descriptions, level of concern analyses, traceability matrices, and verification and validation summaries.
- Develop cybersecurity submission content including threat models, cybersecurity risk assessments, SBOMs, and vulnerability and patch management plans.
- Serve as a technical subject matter expert for regulatory affairs, quality, clinical, and other cross-functional teams.
- Respond to FDA Additional Information requests and deficiency questions involving software and cybersecurity content.
- Support QMS activities including design controls, SDLC documentation, DHF maintenance, SOPs, audits, inspection readiness, CAPAs, non-conformance investigations, root cause analyses, complaints, and post-market activities.
- Translate regulatory requirements into actionable engineering tasks within agile and iterative development workflows.
Requirements
- Bachelor's degree in software engineering, computer science, computer engineering, biomedical engineering, or a related technical field; an advanced degree is a plus.
- 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.
- Understanding of medical device software SDLC processes, IEC 62304, ISO 14971 risk management, and 21 CFR Part 820 design controls.
- Experience with threat modeling, SBOM preparation, vulnerability management, QMS activities, DHF documentation, CAPAs, and internal audits.
- Strong technical writing skills and the ability to produce regulator-ready software documentation.
- Ability to advise regulatory, quality, and clinical stakeholders on software and cybersecurity topics.
- Proficiency with modern software development practices, version control, CI/CD, and agile methodologies in regulated environments.
- Preferred qualifications include experience with cloud-hosted or AI/ML-enabled regulated software, FDA DHCoE policies, Computer Software Assurance guidance, EU MDR/IVDR documentation, medical-device cybersecurity frameworks, SCA tools, static and dynamic analysis tools, penetration testing, and CSQE or similar certification.
Benefits
- Medical, dental, and vision insurance.
- 401(k) retirement plan and paid time off.
- Additional benefits may include relocation assistance.
- Additional compensation may include annual performance bonuses and discretionary bonuses.
- A resume or CV is required for the online application; applicants are encouraged to submit a cover letter and transcript.
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About Hogan Lovells
Hogan Lovells is a global law firm providing corporate, finance, regulatory, and dispute-resolution counsel to corporations, financial institutions, and governments. Structured as a partnership and headquartered in Washington, DC, it combined with Cadwalader, Wickersham & Taft on 1 July 2026 to form Hogan Lovells Cadwalader. The firm advises across banking, insolvency, competition/EU, arbitration, employment, energy, and financial services matters in cross-border markets.