Requirement Analyst

Requirement Analyst

Cognizant is seeking a sharp and detail-oriented Requirement Analyst to join our Radiation Therapy QA platform team. The ideal candidate will work closely with client Product Line Directors and client Technical Product Managers to gather, analyze, and document requirements for software development in a regulated medical device environment. This role demands quick learning, strong collaboration, and the ability to translate customer needs into actionable user stories.

Key Responsibilities:

· Collaborate with stakeholders to elicit, analyze, and document business, functional, and non-functional requirements.

· Translate high-level requirements into detailed user stories in JIRA with clear descriptions, acceptance criteria, and mock-ups.

· Define and document entry and exit criteria for user stories to ensure clarity and alignment across teams.

· Ensure compliance with medical device software regulations (21 CFR Part 820, ISO 13485).

· Act as a subject matter expert, supporting development, QA, and validation teams throughout the SDLC.

· Participate in agile ceremonies including sprint planning, backlog grooming, and sprint reviews.

· Maintain traceability of requirements from origin through implementation and verification.

· Collaborate with QA to ensure comprehensive test coverage of all requirements.

· Engage with the Customer Product Management team to understand customer needs and convert them into actionable requirements.

Qualifications and Skills:

Must Have:

· Bachelor’s degree in Computer Science, Engineering, Biomedical Engineering, or related field.

· Proven experience as a Requirement Analyst or Business Analyst in a regulated medical device (SaMD) environment.

· Experience in the field of Medical diagnostic, radiation therapy, medical physics, medical imaging or oncology informatics.

· Experience Strong knowledge of 21 CFR Part 820, ISO 13485, and IEC 62304.

· Proficiency in agile development methodologies and extensive experience with JIRA for managing product backlogs and user stories.

· Excellent analytical, problem-solving, and communication skills, with the ability to bridge the gap between technical and non-technical stakeholders.

· Strong attention to detail and a commitment to producing high-quality work.

Good to Have:

· Expertise in medical documentation.

· Familiarity with radiation therapy QA software.

· Certified Scrum Product Owner (CSPO) or similar agile certification.

· Experience with tools like Jama or DOORS for requirements management.

Ideal Candidate Profile:

· Sharp, proactive, and quick learner.

· Comfortable working onsite and closely with cross-functional teams.

· Able to effectively bridge technical and non-technical discussions.

· Capable of converting customer feedback into structured requirements.