Software Quality Engineer (SQE)

Software Quality Engineer (SQE) At Terumo Blood and Cell Technologies, we produce medical devices and related products for blood and cell processing. We are seeking a Software Quality Engineer (SQE) who will ensure secure, compliant, and high‑quality software across both new product development and sustaining products. Job Summary The SQE owns test design and is accountable for defining what is tested, ensuring comprehensive coverage aligned to requirements, risk, and regulatory expectations. The role partners closely with Software Development, Systems Engineering, DevOps, and global teams to embed quality into the product lifecycle and consistently execute across distributed environments. Essential Duties Define test strategy and coverage based on risk, system behavior, product requirements, and regulatory expectations. Develop and maintain comprehensive, repeatable, and traceable test cases aligned to requirements and risk. Design high‑quality test cases with clear manual and automation‑ready steps, and provide implementation instructions for SDETs. Determine which test cases should be automated versus manual based on risk, repeatability, efficiency, and overall value. Partner with SDETs to ensure automated test implementation aligns with defined test cases and overall quality engineering strategy. Review and approve test cases to ensure consistency, completeness, and repeatability across global execution teams. Evaluate and review test execution results, interpreting outcomes accurately. Investigate test failures, determine root cause (test vs software defect), and document defects appropriately. Maintain end‑to‑end traceability from requirements and risk controls through test cases, execution, and verification results. Participate in requirements reviews and provide feedback to ensure clarity, completeness, and testability. Conduct and document thorough impact assessments to identify affected requirements, test cases, and system components for changes and releases. Support shift‑left and continuous quality practices by collaborating with development, systems, and DevOps teams throughout the lifecycle. Other Duties and Responsibilities Contribute to continuous improvement of SQE processes, tools, and practices. Support cybersecurity and performance testing efforts through test design and execution. Ensure compliance with regulatory requirements through proper documentation, traceability, and verification practices. Collaborate with global teams to ensure test cases are executable with a defined baseline level of product knowledge. Minimum Qualification Requirements Education: Bachelor's degree in Computer Science, Engineering, or equivalent of education and experience sufficient to successfully perform the essential functions of the job. Experience: Minimum 8 years of experience in software quality engineering, software test, or a related role; experience in regulated environments (e.g., medical device, aerospace) preferred. Skills: Strong expertise in test case design, including manual and automated test development. Ability to determine appropriate test approach (manual vs automated) based on risk and value. Deep understanding of risk‑based testing and requirements coverage. Strong knowledge of software development lifecycle and shift‑left quality practices. Experience with traceability and regulatory compliance requirements. Ability to create clear, repeatable, and globally executable test cases. Strong analytical and problem‑solving skills, including root cause analysis. Experience collaborating with SDETs and understanding automation frameworks. Familiarity with AI‑assisted tools and modern quality engineering practices. Strong communication skills and ability to work across cross‑functional teams. Experience working in global, distributed team environments. Commitment to continuous learning, improvement, and adoption of best practices. Physical Requirements: Hybrid position requiring a minimum of 3 days a week at the Lakewood, CO headquarters. Typical office environment demands reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. Reasonable accommodations may be made for individuals with disabilities. Target Pay Range: $127,300.00 to $159,100.00 (salary to be determined by education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data). Benefits: Competitive compensation, medical, dental, vision benefits, wellness program, 401(k) plan with matching contribution, vacation and sick time, life insurance, disability coverage, and additional voluntary programs. Equal Opportunity Statement: We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. #J-18808-Ljbffr