Software Validation Engineer Are you looking for a great work culture, good teammates, and caring leadership? Ortho Development is the place to be. We offer great benefits, working Monday through Friday. Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in Draper, Utah. We offer a complete benefits package, clean work environment, and thorough training. As the Software Validation Engineer, you will play a key role in ensuring that all software systems used in the development, manufacturing, quality control, and post-market support of our orthopedic implant products meet the highest regulatory and quality standards. Reporting directly to the Senior Director of QA/RA, you will be responsible for planning, executing, and documenting software validation activities in compliance with FDA 21 CFR Part 820, Part 11, ISO 13485, GAMP 5, and other relevant industry standards. Your work will be critical in supporting the design, manufacturing, and life-cycle management of Ortho Development’s knee, hip, spine, and trauma products. Schedule: Monday to Friday Location: Onsite, Draper UT Primary Responsibilities Develop and maintain the overall software validation strategy, ensuring alignment with corporate goals and regulatory requirements (e.g., FDA 21 CFR Part 820, Part 11, and ISO 13485). Collaborate with cross-functional teams (R&D, IT, Manufacturing Engineering, Quality) to identify software systems requiring validation, define validation scope, and establish timelines. Author and review validation deliverables, including validation plans, protocols (IQ/OQ/PQ), test scripts, risk assessments, and final reports. Ensure comprehensive and accurate documentation of all software validation activities, maintaining clear traceability to user requirements and regulatory standards. Coordinate and conduct hands-on testing activities, including functional, integration, and system-level testing of software applications (e.g., PLM, ERP, MES, LIMS). Analyze test results, document deviations or anomalies, and work with project teams to drive timely resolutions. Perform software risk assessments (e.g., FMEA), identifying and mitigating potential hazards or compliance gaps related to software functionality. Ensure that validated systems maintain compliance over their life cycle, including changes, upgrades, and periodic reviews in alignment with GAMP 5 guidelines and Part 11 requirements. Support internal and external audits by demonstrating compliance, providing relevant documentation, and implementing corrective actions where necessary. Partner with stakeholders (e.g., QA, RA, IT, Engineering) to ensure alignment and effective communication regarding software validation requirements, progress, and outcomes. Provide technical input and mentorship to project teams on software validation best practices and regulatory expectations. Identify opportunities to enhance software validation processes, leveraging industry best practices and emerging technologies. Keep abreast of evolving regulations and standards related to software validation, sharing insights with the broader QA/RA and IT teams to maintain a state-of-the-art validation program. Perform other job-related duties as assigned. Training and Experience Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field. 7 years of experience in software validation, preferably within the medical device or pharmaceutical industry. Familiarity with orthopedic implant products (knee, hip, spine, trauma) is highly desirable. Proven track record in managing and executing software validation projects under FDA 21 CFR Part 820, Part 11, ISO 13485, and GAMP 5 guidelines. Strong understanding of validation methodologies (IQ/OQ/PQ), risk management (ISO 14971 or equivalent), and quality management systems. Proficiency in creating and executing test scripts, using test management tools, and documenting outcomes in a regulated environment. Knowledge of software development life cycle (SDLC) models, configuration management, and change control processes. Excellent communication and interpersonal skills, with the ability to collaborate effectively across technical and non-technical teams. Detail-oriented, analytical mindset with strong problem-solving and decision-making capabilities. Ability to manage multiple priorities in a fast-paced environment while maintaining a commitment to quality and compliance. Benefits: We offer competitive compensation and excellent benefits including: 401(k) 401(k) matching Dental insurance Employee assistance program Employee discounts Flexible spending account Health insurance Life insurance Paid Holidays Paid time off Parental leave Tuition reimbursement Vision insurance Wellness incentives UTA Transit Pass