Job Description:
We are seeking an experienced Software Requirements Coordinator with strong Business Analysis skills to join our team. A background in Quality Assurance is a plus. In this dual role, you will act as a key liaison between stakeholders, the development team, and QA, ensuring seamless communication and coordination. You will take the lead of the software requirements definitions, while proactively analyzing, reviewing, and refining product requirements for software applications used in clinical diagnostic instruments. Your work will ensure that our solutions meet the highest standards of quality, compliance, and functionality, critical for use in clinical environments.
Key Responsibilities
Business Analysis:
- Define, document, and manage software requirements based on stakeholder input and regulatory needs, maintaining clear alignment with project goals.
- Analyze and interpret complex business needs, translating them into detailed functional and technical specifications.
- Facilitate cross-functional collaboration, ensuring development and quality assurance are integrated with regulatory requirements and client expectations.
- Continuously refine processes to enhance requirement traceability and ensure robust software solutions that meet stakeholder and regulatory expectations.
Software Quality Assurance (Additional Scope):
- Manage bug tracking and oversee testing for compliance, usability, and performance for software interacting with diagnostic hardware.
- Work with cross-functional teams to troubleshoot and resolve issues, ensuring high-quality standards throughout the development lifecycle.
- Monitor and report on testing progress, and provide clear documentation of results, including defect tracking and resolution.
- Contribute to Development, execution, and documentation of comprehensive test plans and test cases to verify software functionality, performance, and compliance with industry standards and regulatory requirements.
Qualifications:
- Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Computer Science, Clinical Diagnostics).
- Proven experience (3+ years) in software product management and requirements definitions, ideally with medical or clinical diagnostic applications.
- Advantage: Experience in software Quality Assurance and relevant documentation (STP, STD etc.), ideally with medical or clinical diagnostic applications.
- Strong background in requirements gathering, analysis, and documentation.
- Excellent analytical skills, attention to detail, and experience with BA and SQA tools and methodologies.
- Proficiency in English; other languages are an advantage.
Preferred Skills
- Knowledge of software development methodologies (e.g., Agile, Scrum)
- Experience with requirement management tools and quality management systems (e.g. JIRA, Jama, Azure DevOps Test Plans, MTM).
- Prior work with medical devices or diagnostics companies.
- Knowledge of regulatory compliance in the medical field (FDA, ISO) and risk management processes.
- Certifications in or Business Analysis (CBAP) or Quality Assurance (ISTQB) are a plus.
