Senior Software Quality Engineer

Base Pay $110,000.00 - $140,000.00 / Year Job Category Computer Science, Engineering Industry Manfuacturing, Regulations Employee Type Exempt Full Time Required Degree 4 Year Degree Travel 10% 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 Assures a safe work environment Encourages individual development and demonstrates teamwork and flexibility/adaptability Demonstrates honesty Keeps commitments Think systemically and ensures constancy of purpose Leads with humility and respects every individual Focuses on process, embraces scientific thinking, flows and pulls value, ensures quality at the source and seeks 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) Benefits Estimated starting annual base salary range is $110,000 – $140,000, with the target base compensation in the low‑to‑middle of the range. Compensation may vary based on location, experience, qualifications, education, skillset, and market conditions. TIDI Products offers a competitive benefits package to eligible full‑time employees, including medical, dental, and vision plans; 401(k) with employer matching contributions; life insurance; paid time off; tuition reimbursement; paid sick leave in accordance with applicable law; and other benefits subject to eligibility requirements. 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 consideration for employment without regard to race, color, religion, sex, age, disability, marital status, family status, national origin, age, or any protected characteristic. #J-18808-Ljbffr