Software Systems Analyst (US Remote)
Vacancy expired!
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 Sciences Division How will you make an impact?With your QMS experience, you 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. 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. Your contributions will help 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.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.
- Bachelor's in Computer Science, Biotechnology, or related scientific discipline
- 5+ years of experience with software development best practices, such as Agile or SCRUM
- 5+ years industry experience in a systems/business analyst role
- Experience with formal requirements management and modeling tools, such as DOORS, Visio and UML
- Experience with requirements gathering and workshop facilitation
- Knowledge in or ability to learn QSR design controls (21 CFR 820), ISO 13485, IEC 62304, ISO 14971 and IVD product development processes
- Experience in Life Sciences, Genomics, or Pharmaceutical industries and/or molecular/DNA technology
- Experience in clinical software/product development in an FDA IVD regulated or CLIA laboratory environment
- Experience conducting UX/usability testing with end users and interviewing customers to gather user needs
- Ability to provide a structured approach to requirements elicitation and management, with flexibility to adapt to the needs of different projects
- Comfortable working as part of a distributed, global, and cross-functional team
- Prepared to work to aggressive timelines in an iterative software development environment
Vacancy expired!