Staff Software Validation Engineer

Role Overview:The Staff Software Validation Engineer provides expertise and technical guidance to Smith+Nephew Orthopedics regarding all aspects of software applications and Process Validation for medical products, manufacturing systems, and software systems. The role provides guidance to all S+N locations for the Process Validation and validation of manufacturing systems, web-based applications, and medical device software.• Coordinates all process/software validation activities through constant communication with affected department personnel including Quality Assurance, Product Development, Marketing, and Regulatory Affairs.• Conducts process/software system compliance assessments on multiple types of systems.• Develops Standard Operating Procedures for the validation and control of process and software systems.• Acts as Project Leader on multiple projects involving software applications for products and manufacturing process systems.• Acts as Project Leader in the auditing of process and software systems.• Responds to regulatory agencies regarding questions concerning process and software validation.• The position interacts with all levels of management to communicate software/process validation requirements and project schedules.Responsibilities:(70%) Overseeing projects associated with software design control and software validation to ensure that project deliverables meet target delivery dates. This role works to mitigate issues that could result in a project delay or compliance issue via direct and indirect employee engagement.(10%) Serve as the subject matter expert for software. Participating in cross functional meetings and serving a software representative from the Quality organization. Identify and implement proactive solutions that drive efficiencies within software validation and design control processes and requirements. Leading and working as team member with groups assigned to enhance software technologies within the organization(10%) Maintaining the software quality management system is a state of compliance. Support internal and external audits. (10%) Providing internal training to increase employees'' knowledge of software requirements, and developing other validation engineers to increase his/her skills in software validation and working in teams. May act as Software Validation Manager on an interim basis.Location: Memphis, TNEducation: Minimum BS in Computer Science, Electrical Engineering, Biomedical Engineering or other related engineering fields. Advanced degree preferred.Experience:BS + 6 years of relevant experience, including a minimum of 3 years'' experience working to control software in a regulated industry, ORMS + 3 years'' experience working to control software in a regulated industryExperience with working with cross functional team environments. Experience with developing and maintaining software specifications and implementing best practices.Source code and software management control experience required.Knowledge of C and C++ preferred.Knowledge of Graphical User interface design and programming, networked systems and data sharing technology petencies: Thorough understanding of FDA''s requirement for software controls. Understanding of MDR regulation for software control21 CFR Part 11 - Electronic Records & Electronic Signature21 CFR Part 820 - Quality System RegulationGeneral Principles of Software ValidationHealth Insurance Portability and Accountability ActIEC 62304 - Medical Device Software - Software Life Cycle ProcessISO 13485- Medical Device Quality Management SystemISO 14971 - Medical Devices - Application of Risk ManagementProject Management experienceSoftware validation experienceSoftware design control experienceExcellent analytical, problem solving and organizational skillsHigh Learning agilityStrong written and verbal communication and technical writing skillsTravel Requirements: Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Created: 2026-05-02