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.Division Specific Information/Location
Genetic Testing Solutions / position will be remote or site based preferably in South San Francisco, CAHow will you make an impact?
You will ensure that software projects run on schedule, meet scope and requirements, and all software activities and tasks are completed in accordance with design compliance in an FDA regulated environment. The role involves attending core team meetings; coordinating with project team members outside of the software group; preparing, maintaining, and overseeing software plans and report documentation; resource planning and management; and resolution of issues that arise throughout the software development cycle. You will also be responsible for coordinating all software activities to ensure timely completion, overcome obstacles, and mitigate identified risks.What will you do?
• Collaborate with product management and key stakeholders to define the scope of each software release, with an eye on the product development roadmap
• Plan and manage software development, testing and related activities and timelines for clinical software development projects
• Estimate overall engineering effort and collaborate with management to acquire and enable the necessary resources
• Author, review, and approve software development plans and report documentation, ensuring design compliance for clinical laboratory software
• Drive process improvement in software development and test methodologies, such as tracking software activities, project metrics reporting, and creating efficiencies
• Ensure all software activities are accomplished in accordance with FDA guidance, design compliance with internal procedures, and suitability to intended use of the clinical product
• Ensure that all projects toolsets and environments are in place for the project and are adopted and properly used by the software engineering team
• Participate in Software Hazard Analysis activities to ensure a full understanding of patient and safety risks for clinical software products. Ensure that risk control measures are implemented correctly and verified accordingly with suitable traceability.
• Collaborate with algorithm engineers to coordinate algorithm integration into the software development schedule
• Ensure completion and delivery of trace matrix from product requirements to test case resultsHow will you get here?
B.S. in Computer Science, Molecular Biology, Biology, Microbiology, Biochemistry, or related technical disciplineExperience
• 3+ years of experience managing projects in a regulated environment (medical device, aerospace, defense, etc); experience in a clinical/diagnostic laboratory setting or FDA regulated environment is preferred
• 5+ years of experience leading software teams
• Experience with laboratory workflows in a clinical diagnostic environment is preferred
• Extensive experience in new product development from product realization to product launch
• Utilized Jira, MS Project, DOORS Next Generation, HP ALM
• Agile software development methodologyKnowledge, Skills, Abilities
• Ability to clearly communicate overall health of the product and status updates to key stakeholders
• Deep understanding of qPCR and IVD genetic testing workflows in a clinical laboratory is highly preferred
• Project planning and manage multiple work streams concurrently
• Familiarity with IEC 62304, ISO 13485, ISO 14971, ISO 9001, and 21 CFR Part 820 is preferredRelocation 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 .
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