Software Project Manager
Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: July 14, 2021
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.
When you’re part of the team at Thermo Fisher Scientific, you’ll
do important work, like helping customers in finding cures for
cancer, providing COVID-19 testing to laboratories across the globe
to address the global pandemic, and developing new tests for
infectious and inherited disease. Your work will have real-world
impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
As Software Project Manager for Genetic Testing Solutions, you
will ensure that software projects run on schedule, meet scope and
requirements, and that 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'll coordinate all software activities to ensure timely
completion, overcome obstacles, and mitigate identified risks.
Ideally, the project lead will possess a deep understanding of
qPCR and IVD genetic testing workflows in a clinical laboratory.
This role will provide leadership and guidance to the software
engineering team to ensure the highest quality standard of product
in an FDA-regulated environment.
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
- 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
- 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
- Participate in Software Hazard Analysis activities to ensure a
full understanding of patient and safety risks for clinical
- 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.
- Clearly communicate status of software product development to
key stakeholders via status updates.
- Ensure completion and delivery of trace matrix from product
requirements to test case results.
How will you get here?
- Bachelors degree and 8 years related industry experience/
Advanced degree and 6 years related industry/ Educational
equivalency with additional industry experience may be
- B.S. in computer science or in molecular biology, biology,
microbiology, biochemistry, or similar scientific discipline.
- Familiarity with laboratory workflows in a clinical diagnostic
- Experience in new product development from product realization
to product launch.
- 3+ years of experience managing projects in a clinical or
diagnostic laboratory setting and an FDA regulated
- 5+ years of experience leading software teams
- Project planning and advanced computer skills a plus.
- Ability to manage multiple work streams concurrently.
- Experience with Jira, MS Project, DOORS Next Generation, HP ALM
- Experience in Agile software development methodology
- Familiarity with IEC 62304, ISO 13485, ISO 14971, ISO 9001, and
21 CFR Part 820 preferred.
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.
Keywords: Thermo Fisher Scientific, South San Francisco , Software Project Manager, Other , South San Francisco, California
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