Team Description:

Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards by streamlining operations and enhancing efficiency through innovative process development. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance.

Job Description and Responsibilities:

As a Software Verification & Validation Engineer, you will play a critical role in upholding the integrity of our software systems within a highly-regulated medical device environment. This position involves overseeing validation activities to ensure software meets FDA requirements, including 21 CFR Part 11, 21 CFR Part 820 and SaMD/SiMD guidelines, while collaborating across teams to support the development of new software tools. Specifically, you will:

• Sustain software V&V activities ensuring ongoing compliance and performance
• Own the software V&V program, including development, revision, and maintenance of Standard Operating Procedures
• Serve as the subject matter expert on 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and other SW Validation Standards for driving overall compliance with FDA guidelines
• Conduct design controls, code reviews, unit tests, creation and review of sBOMs, and related activities to verify software integrity per regulatory standards
• Act as a Quality liaison with core software teams for the development and validation of internal systems
• Develop and own SaMD/SiMD compliance for our devices, including clinical evaluation, analytical validation, and risk management
• Develop and execute validation protocols, test plans, scripts, and reports to document software performance, including integrated verification activities with limited supervision
• Develop an automated V&V process for SW back-end testing
• Perform software risk assessments and contribute to hazard mitigation strategies
• Support regulatory audits, inspections, and submissions with comprehensive documentation
• Validate and verify software utilized across various divisions, including custom and off-the-shelf software
• Apply knowledge of high-level programming languages to create new test protocols, debug existing ones, and resolve issues

Required Qualifications:

• Bachelor's degree in software engineering, computer science, biomedical engineering, or a related field
• 1+ years of experience in a regulated field performing software design, verification, or validation, preferably in the medical device or pharmaceutical industries
• Proficiency in validation tools, scripting (e.g., Python), and code review processes
• Excellent analytical, problem-solving, and communication skills, with the ability to collaborate across interdisciplinary teams

Preferred Qualifications:

• 3+ years in medical device software validation, with hands-on IEC 62304 lifecycle experience
• Familiarity with risk management standards like ISO 14971, as well as IEC 60601 and other relevant medical device standards
• Experience in post-market surveillance and software updates in regulated environments
• Expertise in SaMD compliance, including FDA guidance on clinical and analytical validation
• Hands-on experience with software development lifecycle methodologies, including Agile and SAFe
• Proficiency with defect tracking tools (e.g., Jira) and statistical software (e.g., Minitab)
• Experience with regulatory agencies and standards like 21 CFR 820, ISO 13485, and IEC 62304/82304