When you're part of the team at Thermo Fisher Scientific, you'll do important work, and you'll be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you'll find the resources and opportunities to make significant contributions to the world.
What we are looking for:
This 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.
This 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.
What you will do:
- Work with stakeholders for requirements gathering and analysis for new platform. During this phase you would be interacting with business team to capture functional requirements and analyze them in terms of application and map it with technical requirements.
- Consult with researchers to analyze problems, recommend technology-based solutions, or determine computational strategies.
- Maintaining all requirements documented in User stories and update as and when required.
- Become familiar with the needed biological context for the software being developed.
- Complete ownership of logical verification of the developed module from informatics domain point of view.
- Process, analyze, and interpret experimental and clinical datasets derived from research and validation studies.
- Analyzing algorithm performance by evaluating results to choose the best solution and solve problems.
- Keep up to date with relevant algorithm and software developments.
- For backend validation, as required write scripts to prepare analyses input files and extract summary results and statistics from analysis outputs.
- In algorithm development cycle, conduct initial processing and QC of the analysis pipeline being developed.
- Contribute to refine existing analysis protocols.
- Development or modification of pre-existing additional analysis components, such as in-analysis plugins, as required.
- Owning end-to-end verification and testing of analysis pipeline to be released for external partners.
- Collaborating with experimental, clinical and bioinformatics scientists to stay informed about the design of the module.
- Work closely with customers and informatics domain team to finalize and realize business scenarios.
- Bachelors degree and 8 years industry experience in a systems/business analyst role/ or bioinformatics tester/ 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, HP ALM, 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, and 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.
- Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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