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.
How will you make an impact?
The System Analyst role will be responsible primarily for preparing
product requirements and specifications, conducting software hazard
analysis activities, contributing to software user interface
design, and improving user experience of our software products.
The System Analyst role will conduct requirements workshops with
team members and meet with individuals of various scientific,
software, and product development disciplines to gather and
document measurable, testable, and traceable requirements and
specifications. Responsibilities will also include interviewing
customers for feedback, conducting software usability testing, and
contributing to UI/UX design activities.
Your experience with QMS will provide design compliance input to
the software engineering teams, including, but not limited to,
authoring, reviewing, and approving software-related deliverables,
such as Risk and Hazard Analysis, Software Requirements and
Specifications, Design Verification and Validation Plans and
Reports, Pre-market and Post-market Change Control.
Your passion for customer satisfaction and patient safety in a
clinical setting will help to evangelize cultural improvement and
discipline in design compliance for software planning, development,
design, verification, maintenance, and support in an FDA-regulated
clinical environment for both New Product Introductions (NPIs) and
Sustaining software releases.
You will contribute to process improvement and prepare training
materials around design compliance for the GSD software group, and
maintain work instructions and procedures for all aspects of
software product development in an FDA regulated environment.
What will you do?
Prepare well-written technical requirements, functional
specifications, and diagrams for complex scientific algorithms and
genetic instrumentation, including documenting workflows and error
Apply best practice methodologies in developing and maintaining
requirements deliverables, including user stories, use cases,
functional requirements, non-functional and performance
requirements, and business rules.
Facilitate requirements workshops and hazard analysis activities
with cross-functional science, engineering, and product management
teams to elicit and review technical requirements and risk controls
for new and sustaining software products.
Manage requirements, prepare analysis models and diagrams, and
generate reports using IBM DOORS Next Generation (DNG), Excel, and
Visio or similar.
Collaborate with test team to ensure requirements and
specifications are concise, accurate, measurable, and testable.
Establish traceability between product requirements,
specifications, and test cases/results. Prepare trace matrix
Participate in Voice of Customer (VOC) activities to elicit user
needs for product development.
Contribute to user interface design and usability testing
activities for web-based software to provide a seamless user
experience in navigating complex scientific laboratory
Collaborate with UX engineers and UI designers to prepare
mockups and prototype user interfaces for complex life-science
domain software that meets the needs of our customers.
Participate in complaint handling, troubleshooting, technical
support, and change control activities for post-market release
software products in an FDA regulated environment.
Prepare and contribute to design compliance documentation and
best-practice disciplines across all aspects of software
development within the SDLC.
How will you get here?
Bachelors degree and 5 years industry experience in a
systems/business analyst role/ Advanced degree and 3 years industry
/ Educational equivalency with additional industry experience may
Minimum 4 years of experience with software development best
practices, such as Agile or SCRUM.
Experience with formal requirements management and modeling
tools, such as DOORS, Visio and UML.
Experience with requirements gathering and workshop
Well-versed in QSR design controls (21 CFR 820), ISO
13485.Experience in IEC 62304, ISO 14971 and IVD product
development experience is a plus.
Knowledge, Skills, Abilities:
Attention to technical detail, solid written and verbal
communication skills, and ability to analyze and navigate technical
problem domains are required. Previous experience in a fast-moving
biotechnology environment preferred.
Provides a structured approach to requirements elicitation and
management, with flexibility to adapt to the needs of different
Possess strong written and verbal communication, presentation,
and facilitation skills.
Comfortable working as part of a distributed, global, and
Prepared to work to aggressive timelines in an iterative
software development environment.
Background in software and/or biotechnology.
Experience in clinical software/product development in an FDA
IVD regulated or CLIA laboratory environment highly desirable.
Experience conducting UX/usability testing with end users is a
Experience interviewing customers to gather user needs is a
Experience in Life Sciences, Genomics, or Pharmaceutical
industries. Experience with molecular and/or DNA technology is
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 , Systems Analyst, Other , South San Francisco, California
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