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 Senior 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 Senior 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 handling scenarios.
- 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 reports.
- 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 workflows.
- 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 8 years industry experience in a systems/business analyst role/ Advanced degree and 6 years industry / Educational equivalency with additional industry experience may be considered.
- Minimum 5 years of experience with software development best practices, such as Agile or SCRUM.
- Experience in Life Sciences, Genomics, or Pharmaceutical industries.
- Experience with molecular and/or DNA technology is highly desirable.
- Experience with formal requirements management and modeling tools, such as DOORS, Visio and UML.
- Experience with requirements gathering and workshop facilitation.
- 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 projects.
- Possess strong written and verbal communication, presentation, and facilitation skills.
- Comfortable working as part of a distributed, global, and cross-functional team.
- Prepared to work to aggressive timelines in an iterative software development environment.
- Background in software and/or biotechnology is a plus.
- 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
- Experience interviewing customers to gather user needs
- Experience in Life Sciences, Genomics, or Pharmaceutical industries. Experience with molecular and/or DNA technology is highly desirable.
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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