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Software Test Engineer

Organization

Thermo Fisher Scientific

Job Location

180 Oyster Point Blvd
South San Francisco, CA 94080
United States

Salary

Competitive base salary based upon background, experience & education

Benefits

Comprehensive benefits & bonus package

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific Information
South San Francisco, CA / Genetic Testing Solutions

How will you make an impact?
You will ensure the integrity, accuracy, and design compliance of software testing in an FDA regulated environment. The role involves quality and test advocacy, test resource planning and management, and resolution of issues that impede the testing effort. You'll coordinate software testing activities to ensure the software is fit for intended use, mitigates all identified risks, and is free of unexpected anomalies.

What will you do?
• Author test case protocols in collaboration with R&D during system development, ensuring test coverage across happy-path and alternative path workflows, as well as error handling scenarios
• Execute test protocols in a laboratory environment
• Prepare execution reports and consolidate into verification reports
• Establish and maintain traceability of test cases in protocol to product requirements and specifications
• Ensure design compliance, test coverage, and suitability of protocols for clinical laboratory software and integrated systems, including liquid handling robotics
• Determine the appropriate test measurements and metrics for genetic testing software products, including high-throughput integrated systems and clinical analytical software
• Adhere to verification, validation, and defect management procedures, in accordance with FDA guidance and design compliance work instructions for verification of medical device software – IEC 62304 – to ensure suitability to intended use of the clinical product
• Ensure test toolsets are properly maintained, validated, and documented according to FDA guidance on Validation, and that the test environment is in place prior to test execution
• Participate in Software Hazard Analysis activities to ensure a full understanding of patient and safety risks for our clinical software products, and ensure that risk control measures are implemented correctly and tested accordingly
• Collaborate with algorithm engineers to develop algorithm test plans and integration verification protocols
• Communicate issues related to stability of product features to software team, R&D, and team leads

Requirements

How will you get here?
Education

B.S. in Molecular Biology, Biology, Microbiology, Biochemistry, or related technical discipline

Experience
• 2+ years of experience testing desktop or web-based applications in a clinical or diagnostic laboratory setting and in a FDA regulated environment
• Experience in new product development from product realization to product launch
• Familiarity with laboratory workflows in a clinical diagnostic environment
• Utilized HP ALM, Jira, DOORS Next Generation
• Prior experience in Agile software development methodology

Knowledge, Skills, Abilities
• Knowledge with laboratory workflows in a clinical diagnostic environment
• Ability to clearly communicate overall health of the product and status updates to key stakeholders
• Ability to manage multiple work streams concurrently
• Understanding of qPCR and IVD genetic testing workflows in a clinical laboratory is highly preferred

Relocation assistance may be provided to those that qualify.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Apply today! http://jobs.thermofisher.com

How to Apply

Interested? Great!  Please go to: 

https://jobs.thermofisher.com/global/en/job/15011…?utm_source=Genomeweb&utm_medium=JobPosting&utm_campaign=R&D                                   

About Our Organization

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

For more information, please visit www.thermofisher.com

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