The posting
This position is focused on understanding client business needs, both problems and opportunities, and recommending solutions that address current and future requirements. Increasingly, this includes using AI tools to prototype concepts quickly and applying Spec-Driven Development to turn requirements into implementation-ready specifications. The Senior BSA works with SaaS and healthcare technology clients from startups to enterprise platforms as the critical link between product managers, UX designers, developers, and other key stakeholders. The role demands independence, adaptability, efficient context switching, strong cross-functional communication, the confidence to push back constructively, and the ability to navigate international client environments, including US and Swiss-based clients, while anticipating downstream impacts and keeping teams aligned. The role also supports regulated healthcare engagements in which Creative Capsule software works with a client's medical device and must be built to meet the EU Medical Device Regulation (MDR). The Senior BSA is expected to know what the MDR (and its supporting standards) require of the software lifecycle, put compliant working practices in place from day one so that later conformity is possible without re-engineering, and carry those practices across engagements.
Responsibilities:
- Understand client business needs by framing the right questions, identifying problems and opportunities, and writing descriptive use cases, then translate them into clear, actionable technical details and ensure two-way understanding
- Recommend implementation options that cover key use cases with minimal complexity, resolve client and development team questions, and reconcile differing stakeholder inputs into a unified vision that keeps specifications and user stories unambiguous as they change
- Document requirements and core system components (inputs, outputs, flows, logic, dependencies) using best practices and tools, adjusting depth to stakeholder understanding and scope, and guide system documentation covering functionality, product architecture, and user and business processes
- Apply Spec-Driven Development (SDD) to produce specifications precise enough to drive AI-assisted implementation, rapidly prototype concepts, flows, and interfaces with AI tools to accelerate stakeholder alignment and validate requirements early, and help extend both practices across client engagements
- Collaborate with the UI/UX team to review user interfaces and contribute to interactive prototypes that support stakeholder clarity, reconciling the client's Figma design source with the specification, raising inconsistencies for client arbitration before implementation, and tracing every approved deviation from evaluated designs
- Define testable parameters, including acceptance criteria, verification methods, and non-functional targets per requirement, so the QA team can verify software functionality and compliance with requirements, and set defect severity classes and known-anomaly handling for milestone acceptance and code freeze
- Maintain alignment between evolving scope and initial requirements, flag discrepancies, run change control against the agreed baseline, separating material changes that need a written change note with effort and schedule impact from simple clarifications, validate delivered solutions against the agreed scope, and contribute to internal best practices and process improvements
- On regulated medical device engagements, lead discovery and gap assessments to determine which MDR, documentation, tooling, and process requirements apply, translate them into everyday working practices for the delivery team, and work with the client's regulatory advisor on software safety classification and documentation depth
- Establish requirements traceability and defect tracking from day one, with every story, ticket, commit, and test tied to its requirement and the traceability matrix exported from the tools rather than assembled by hand
- Identify safety-relevant failure modes as inputs to the client's risk management file, turn the resulting risk controls into traceable requirements, and help isolate safety-relevant functions so the highest documentation class applies to the smallest scope
- Specify software behavior at its boundaries with connected hardware and third-party platforms, working from the device maker's interface specifications (data exchange, device states, pairing, events, offline sync) and from healthcare data platforms and practice management systems to document integration requirements, limitations, workarounds, and data mappings
- Define data protection, access control, and audit trail requirements for health data under Swiss nLPD and EU GDPR, covering authentication, least-privilege access, encryption in transit and at rest, and who, when, and what traceability on every change to clinical or treatment data
- Maintain the project glossary and controlled terminology, including regulatory wording constraints and approved labels per interface language, define localization requirements, and build reusable templates and procedures for regulated engagements
Technical Qualifications:
- Experience eliciting, managing, and documenting requirements for large-scale or complex software applications, modeling business processes and systems with diagrams and workflows (swimlane, flowchart), including AI-assisted generation with Mermaid, FigJam AI, and Draw.io, and preparing structured, navigable, cross-referenced documentation in Confluence, Google Docs, or MS Word
- Experience rapidly prototyping with AI tools such as Lovable, Google AI Studio, Claude Design, or other relevant AI tools (required), able to speak in detail about past AI project work, and an understanding of the business and technical implications of AI projects, such as model integration, data handling, or ethical considerations
- Experience with wireframing and design tools such as Figma for visual specifications and mockups, including the Figma MCP server linking design and AI workflows (broader MCP or agentic tool integration a plus), and working closely with UX/design teams in a SaaS setting
- Experience in clear US English speaking and writing in professional and informal settings, and managing client communications and expectations, including senior-level presentations and demos
- Working knowledge of EU MDR (Regulation 2017/745) and its supporting standards IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366-1 (usability engineering), including how requirements, tests, known anomalies, and third-party component (SOUP) registers link for audit (required), plus experience with Jira-integrated traceability tools such as Ketryx or Greenlight Guru (a plus)
- Understanding of UI/UX best practices, usability principles, how interface design impacts functionality, and SaaS product design principles for web, mobile, and tablet platforms, including field use with unreliable connectivity, and of analytics platforms such as Google Analytics for capturing usage metrics
- Understanding of the complete software development lifecycle (SDLC) and Agile or Scrum methodologies, including how Agile delivery adapts to regulated environments, and familiarity with Spec-Driven Development using GitHub Spec Kit (a strong plus)
- Familiarity with European or Swiss clients and their cultural or compliance nuances, including public sector, healthcare, and home care or medication management organizations (a plus), and working proficiency in French (a strong plus) and German (a plus)
Personal Skills:
- Ability to tailor verbal and written communication from junior developers to executive stakeholders, with strong client-facing skills and the ability to lead discussions independently
- Ability to organize and synthesize information from high-level overviews to technical specs and to visualize and structure abstract requirements into actionable insights, with the rigor for audit-ready documentation proportionate to risk class and phase
- Ability to research industry standards and apply them to new projects, break complex problems into manageable components, and propose alternative approaches to clarify functionality when clients face decision-making challenges
- Ability to prioritize short-term deliverables against long-term objectives while adapting to change, including across concurrent regulated engagements, and to learn and apply new tools, concepts, and technologies quickly
Education and Work Experience:
- Background in CS, IT or related scientific discipline is preferred
- A minimum of 12 years of relevant business analysis experience, preferably in SaaS environments
- At least one full project cycle on medical device software, software as a medical device (SaMD), or comparable regulated healthcare software, with direct involvement in requirements, traceability, and verification (required), and formal training or certification in medical device software lifecycle or quality management, such as IEC 62304 or regulatory affairs (a plus)
