## Description We are hiring a Senior Software Quality Engineer The Senior Software Quality Engineer serves as a technical quality lead for software-enabled medical device systems, acting as a key interface between software engineering, systems engineering, manufacturing, and external partners. This role is responsible for leading software quality and validation activities to ensure compliance with Design Controls, Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD) regulatory expectations, and the successful development and commercialization of connected healthcare solutions. The position contributes to the continuous improvement of software-focused Quality Management System (QMS) processes and ensures that software systems, integrated devices, and data infrastructure are validated, traceable, secure, and compliant across the product lifecycle. This role operates within a layered regulatory framework: Core: ISO 13485 (QMS), ISO 14971 (Risk), IEC 62304 (Software) Extensions: IEC 62366 (Usability), IEC 81001-5-1 (Cybersecurity) Regulatory: QMSR, Software Validation Guidance Modern Practice: CSA, GAMP 5 Essential Responsibilities: • Support and contribute to the development and continuous improvement of software-specific QMS processes • Ensure adherence to established processes for Software Development Lifecycle (SDLC), Design Controls, and risk-based validation approaches •Support configuration, implementation, and use of QMS tools (e.g., EtQ, requirements/test management systems) •Establish and maintain end-to-end traceability per IEC 62304 and QMSR (User Needs ? System Requirements ? Software Requirements ? Verification ? Validation) •Ensure all requirements are complete, testable, and risk-based and aligned with intended use and clinical workflows •Support development and maintenance of the Design History File (DHF) •Lead development and execution of risk-based software validation strategies for assigned systems or projects •Develop and execute test protocols, scripts, and reports, regression testing (manual and automated), negative and edge-case testing •Ensure defects are documented, classified, investigated, and trended •Partner with development teams to identify and resolve defects •Lead validation of assigned system integrations, including device-to-software connectivity and data acquisition, processing, and reporting •Ensure data integrity and accuracy and audit trail / event logging compliance •Support cybersecurity through risk identification and mitigation activities and integration with ISO 14971 processes •Support usability and human factors validation (IEC 62366) •Apply ISO 14971 risk management practices within software development and validation activities •Ensure risks are identified, documented, and mitigated and linked to requirements and verification activities •Support management of SOUP (Software of Unknown Provenance) and third-party and open-source risks •Support internal/external audits and regulatory inspections •Participate in software release readiness activities •Ensure adherence to configuration management processes and change control procedures •Support verification that software baselines are controlled, documented, and approved •Support design transfer to manufacturing and deployment environments •Ensure validation activities support repeatable and scalable deployment •Participate in supplier quality and monitoring activities •Support pilot and deployment activities through real-world validation and performance monitoring •Monitor defects, complaints, and system performance trends •Support post-market surveillance and continuous improvement efforts •Collaborate with software, systems, product, clinical, and manufacturing teams •Provide quality and regulatory input during design reviews •Support alignment of Agile development practices with Design Control and traceability requirements •Provide technical guidance and mentorship to less experienced team members •This role is evaluated for success against metrics such as defect escape rate, traceability completeness, validation cycle time, audit findings, and compliance outcomes. CORE VALUES & GUIDING PRINCIPLES: • Understands internal and external customers • Assure a safe work environment • Encourage individual development Demonstrates teamwork and flexibility/adaptability • Demonstrates honesty • Keep our commitments • Think systemically and ensure constancy of purpose • Lead with humility and respect every individual • Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection Qualifications: • Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field • Minimum 5+ years of experience in software quality engineering, software development or validation, or regulated industry (medical device, pharmaceutical, or similar) • Experience with QMS tools (e.g., EtQ or equivalent), requirements and test management systems • Demonstrated experience supporting Design Controls, risk management, verification and validation execution. • Working knowledge of Design Controls, software validation and SDLC practices • Familiarity with ISO 13485, ISO 14971, IEC 62304, IEC 62366 (Usability), and cybersecurity principles for connected systems • Ability to develop and execute validation documentation, maintain traceability and validation artifacts, and execute risk-based testing strategies • Strong analytical, documentation, and problem-solving skills • Effective communication across cross-functional teams • Ability to work independently and collaboratively • Ability to travel up to 10% (US and Mexico) About TIDI Products… TIDI Products is a market leading manufacturing of disposable infection prevention products and patient safety products, headquartered in Neenah, WI. We have manufacturing and distribution facilities in Neenah, WI, and, Tijuana, MX. TIDI provides best in class products and service to major healthcare products distributors and users worldwide. We Support Care Givers and Protect Patients!! Disability Accommodation For individuals with disabilities that need additional assistance at any point in the application and interview process, please email WIHR@tidiproducts.com or call 920-751-4300 x 4044. Equal Opportunity Employer TIDI Products is proud to be an equal opportunity employer and is committed to maintaining a diverse and inclusive work environment. All qualified applicants will receive considerations for employment without regard to race, color, religion, sex, age, disability, marital status, family. Estimated starting annual base salary pay ranges is $110,000 - $140,000, less applicable withholdings and deductions, paid on a bi-weekly basis. Please note that the actual compensation offered may vary based on relevant factors as determined by the Company, which may include, but is not limited to, location, experience, qualifications, education, skillset, and market conditions. The target base compensation for this role is in the low to middle of the range, with the top of the range reserved for only exceptional circumstances. TIDI Products offers a competitive benefits package to eligible full-time employees, which currently includes medical, dental, and vision plans, 401(k) with employer matching contributions, life insurance, paid time off, tuition reimbursement, and more, as well as paid sick leave in accordance with applicable law. Each benefit is subject to eligibility requirements as specified in plan documents, and the Company reserves the right to modify the benefits it offers from time to time.