Support Clinical Services by eliciting, documenting, and managing requirements for frontend and backend medical-device software. Translate clinical and business needs into detailed user stories, APIs, and acceptance criteria; maintain traceability and regulatory documentation; coordinate cross-functional delivery, review UX/UI mockups, and support releases within a formal SDLC to ensure quality and compliance.
This position is ideal for a Mid-level Business Analyst who will support the Clinical Services team by defining, documenting, and managing requirements for user-facing software products in a regulated medical device environment.
As a Business Analyst, you will collaborate with clinicians, software engineers, and cross-functional stakeholders to translate complex business and clinical goals into clear and testable software requirements. You will play an active part in projects by providing business analysis, best practice research, detailed requirements, user stories preparation, and acceptance criteria definition — covering both frontend and backend systems. This role is critical to ensuring product quality, regulatory compliance, and successful delivery across research and product development initiatives.
Key Responsibilities
Requirements & Backlog
- Own and maintain a clear, structured, and prioritized backlog that reflects end-to-end product and workflow needs across systems; ensure backlog items are well-defined, actionable, and ready for implementation
- Gather, analyze, and document business, clinical, and user requirements for end-to-end workflows spanning multiple services, cloud-native backend systems, and user-facing frontend applications
- Define and document detailed IT requirements for both backend systems (REST API microservices, integrations, data contracts) and frontend applications (UI behavior, user flows, interaction logic)
- Analyze incoming requirements and convert them into well-scoped features, including technical features such as new APIs, new endpoints, and service integrations
Design & Delivery
- Review and provide structured feedback on UX/UI design mockups, ensuring alignment between design solutions and documented functional requirements
- Coordinate delivery processes across Product, Engineering, Clinical, Quality, and Compliance stakeholders
- Support software releases and change requests by reviewing requirements, participating in impact analysis, and ensuring documentation completeness
- Contribute to architectural and design discussions, ensuring requirements are aligned with product and technical constraints
Documentation & Compliance
- Manage and maintain traceability across requirements, design, implementation, testing, and release documentation in accordance with regulatory standards
- Work within a formal SDLC and adhere to regulatory and quality documentation practices
- Set up and continuously improve business analysis processes on the project, suggesting and implementing process enhancements
Stakeholder Engagement
- Interview domain experts to build and maintain a consistent knowledge base and ensure cross-team alignment
- Collect and interpret product signals (qualitative and quantitative) to support product improvements
Skills, Knowledge & Expertise
Education Bachelor's degree in Computer Science, Engineering, Information Systems, or equivalent experience
Experience 2+ years working as a Business Analyst, preferably in regulated, medical, or complex software environments
Technical Skills
- Strong analytical abilities, exceptional documentation skills, and a structured approach to requirements and traceability
- Solid understanding of REST API and HTTP protocol — requests, responses, headers, error codes, and data contracts
- Proven ability to define requirements for both backend (APIs, microservices, integrations) and frontend (UI/UX behavior, user flows, interaction logic) systems
- Experience reviewing UX/UI design mockups and translating design decisions into functional requirements
- Understanding of client-server architecture, microservices, and cloud-native approaches including AWS stack
- Ability to write full and clear user stories with technical details, functional and non-functional requirements
- Clear understanding of SCRUM methodology and rituals
- Knowledge of UML and ability to build different kinds of solution diagrams
- Ability to work autonomously, take ownership of deliverables, and manage deadlines independently
Communication & Collaboration
- Ability to communicate clearly with both technical and non-technical stakeholders in cross-functional settings
- Strong written and verbal English skills
- Collaborative mindset with the ability to work independently, take initiative, and drive cross-functional delivery
- Experience with Agile software development processes
- Experience in Python or SQL
- Familiarity with medical software, research environments, or R&D workflows
- Experience working with SRS, RTM, and formal requirements management frameworks
About
Your growth and well-being:At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:Health and well-being programs to keep you thriving in both body and mind.Employee-exclusive discounts on Invisalign products.Learning opportunities through online learning resources and support for your individual development plans.Inclusive, global workplace that fosters collaboration, recognition and belonging.Country and/or role specific details will be shared with you by your recruiter during the interview process. Discover Align:We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time. As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.Eager to learn how we embrace our global differences and nurture employee well-being? Explore Align's culture here!Want to discover more about exocad and Cubicure? Click on their names for additional information.
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