Quality Engineer Medical Devices Jobs in Colorado

Requisition ID:  35237  

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

Software Quality Test Engineer (SQE)

JOB SUMMARY

The Software Quality Engineer (SQE) is responsible for ensuring the delivery of secure, compliant, and high-quality software across both new product development and sustaining products. This role operates within a modern Software Quality Engineering model, grounded in shift-left and continuous quality principles, with a strong focus on early defect prevention, robust verification, and full lifecycle traceability.

The SQE owns test design and is accountable for defining what is tested, ensuring comprehensive coverage aligned to requirements, risk, and regulatory expectations. This role partners closely with Software Development, Systems Engineering, DevOps, and global teams to ensure quality is built into the product lifecycle and consistently executed across distributed environments.

A critical focus of this role is developing high-quality, repeatable, and traceable test cases, ensuring proper distinction between manual and automated testing approaches, and maintaining alignment to the SQE ownership model where automation is implemented by SDETs based on SQE-defined test strategy.

ESSENTIAL DUTIES

• Define test strategy and coverage by determining what to test 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 by defining manual and automation-ready approaches, ensuring appropriate coverage, providing clear test steps, and providing implementation instructions for SDETs.
• Evaluate and 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, coverage, 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, including outputs from global execution teams, and ensure accurate interpretation of results.
• 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 may be considered.

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

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Hybrid position reporting to the Lakewood, CO headquarters a minimum of 3 days a week.

Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $127,300.00 to $159,100.00 -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  10.0

We anticipate this requisition will be open for a minimum of five days, from  7/16/2026. We encourage your prompt application.

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

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.