# Software Engineer

**Company**: Hogan Lovells Cadwalader
**Location**: Washington DC
**Experience**: mid
**Job type**: full-time
**Salary**: commensurate with experience
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://hoganlovells.wd3.myworkdayjobs.com/en-US/Search/job/Washington-DC/Medical-Device---Technology--Software-Engineer_R269739?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/software-engineer-d24e950c-2cd/

## Description

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

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## Skills

### Required
- software engineering
- cybersecurity
- FDA regulatory submissions
- Quality Management System (QMS)
- IEC 62304
- ISO 14971

### Nice to have
- cloud-hosted software
- AI/ML-enabled software
- EU MDR/IVDR technical documentation
- cybersecurity frameworks
- software composition analysis (SCA) tools

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Source: [Apply at hoganlovells.wd3.myworkdayjobs.com](https://hoganlovells.wd3.myworkdayjobs.com/en-US/Search/job/Washington-DC/Medical-Device---Technology--Software-Engineer_R269739?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)