Lead Business Analyst/ Product Owner (Healthcare domain) (IRC277646)

Job Description

- Master's degree in Biomedical Engineering, Computer Science, Information Systems, Business Administration, Health Informatics, or a related technical or clinical field.

- 7+ years of experience as a Business Analyst, with at least 2-3 years in a Lead BA or Product Owner role on complex software development projects.

- Proven experience working within medical device industry or a heavily regulated healthcare software environment (e.g., Software as a Medical Device - SaMD).

- Demonstrable experience across the full software development lifecycle (SDLC), with strong experience in Agile/Scrum methodologies. Experience managing requirements backlogs and traceability, preferably using tools like Jira, Confluence, or Azure DevOps.

- Experience working on projects involving medical imaging (CT, MRI, X-Ray), image processing, 2D/3D visualization, or computer-assisted surgery/surgical navigation systems would be a plus.

- Proven experience translating complex clinical needs and workflows into clear, well-documented technical requirements (user stories, specifications, acceptance criteria).

- Familiarity with UI/UX principles and experience collaborating with design teams.

- Understanding of medical device regulations and standards (e.g., FDA QSR - 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, EU MDR).

- Excellent communication skills (written, verbal, presentation) with the ability to effectively communicate complex technical and clinical information to diverse audiences (surgeons, engineers, product managers, executives).

- Strong leadership, facilitation, and negotiation skills. Ability to drive consensus among stakeholders with differing perspectives.

Job Responsibilities

Lead Business Analyst/ Product Owner who will lead the business analysis efforts, ensuring that the developed system accurately reflects clinical needs, enhances surgical workflows, meets regulatory standards, and delivers significant value to surgeons and client

- Lead the elicitation of detailed functional, non-functional, and data requirements from diverse stakeholders, including surgeons (Key Opinion Leaders), product managers, clinical specialists, marketing teams, software engineers, UI/UX designers, and potentially regulatory affairs personnel.

- Manage product backlog by creating it, maintaining and prioritizing based on clinical value, technical feasibility, dependencies, and strategic goals.

-  Conduct in-depth analysis of surgeon needs, clinical workflows (pre-operative planning, intra-operative guidance, post-operative validation), and existing challenges in FAI surgery.

- Provide guidance and mentorship to other BAs on the project, set the standard for BA practices within the project team. Take ownership of the overall business analysis workstream, ensuring quality and timely delivery of BA artifacts.

- Analyze requirements related to processing and analyzing medical imaging data (X-Ray, CT, MRI), including 2D measurements and 3D model generation/manipulation. Investigate and document requirements related to system integration, data management, security, and performance within a clinical/OR environment.

- Develop a strong understanding of hip arthroscopy, FAI pathology, surgical techniques, and the clinical application of medical imaging (X-Ray, CT, MRI). Maintain awareness of relevant medical device regulations (e.g., FDA, CE marking) and standards (e.g., DICOM, HL7) and ensure requirements reflect compliance needs.

- Ensure requirements are effectively communicated, understood, and agreed upon by all relevant stakeholders.

- Act as the primary liaison between the business/clinical stakeholders (client, surgeons) and the technical development team. Facilitate workshops, interviews, and meetings to gather, validate, and refine requirements.

- Build strong relationships with key stakeholders, managing expectations and ensuring alignment throughout the project lifecycle. Present findings, requirements, and proposed solutions to both technical and non-technical audiences effectively.

- Collaborate closely with UI/UX designers to ensure the system interface is intuitive, efficient, and meets the specific needs of surgeons operating in a demanding environment.

- Work with architects and technical leads to ensure proposed solutions are feasible and align with the documented requirements. Participate in design reviews and provide feedback based on business and clinical needs.

- Proactively identify and help mitigate risks and ambiguities related to requirements and scope.

Department/Project Description

We are partnering with a global leader in medical devices to develop the next-generation cutting-edge tool used during hip arthroscopy for femoroacetabular impingement (FAI). Client provides surgeons with real-time visualization and measurement capabilities by superimposing virtual tools on X-ray images, enabling precise clinical decision-making. The product will help surgers to plan and to validate the procedures by analyzing 2D images from X-Rays, CT, MRI and building 3D objects.

Our goal is to enhance the product’s capabilities, improving workflow efficiency and advancing surgical outcomes. This project will involve refining requirements, designing intuitive interfaces, and integrating advanced visualization tools to meet the highest clinical standards. Join us in shaping the future of minimally invasive orthopedic surgery.