Software Engineer

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