Business Systems Analyst
18 hours ago
Business Analyst III
Job Summary
We are seeking a highly skilled Business Analyst III to join our team at ComTec Information Systems. As a Business Analyst III, you will play a critical role in ensuring the successful development and delivery of software solutions that meet the needs of our customers.
Key Responsibilities
Collaborate with cross-functional teams to gather and document software requirements, ensuring traceability throughout the software development lifecycle.
Translate business and regulatory needs into detailed functional and non-functional requirements for software development.
Work closely with the software development team to ensure requirements are understood, feasible, and implemented correctly.
Participate in risk management activities, including hazard analysis and risk assessment, to ensure the safety and efficacy of the software.
Support the development of technical documentation required for regulatory submissions and audits.
Requirements
Bachelor's degree in Computer Science, Engineering, or a related field; advanced degree preferred.
Minimum of 7+ years of experience in a business analysis role, preferably within the medical device industry.
Excellent communication skills, both written and verbal, with the ability to interact effectively with technical and non-technical stakeholders.
Experience with tools such as ADO, JIRA, JAMA, or similar for requirements management and traceability (RTM).
Familiarity with software development processes, particularly within an Agile framework.
Preferred Qualifications
Strong knowledge of IEC-62304, FDA guidelines, ISO 14971, and other relevant standards for medical device software development.
Certification in business analysis (e.g., CBAP, PMI-PBA) is a plus.
Understanding of cybersecurity principles and data privacy regulations (e.g., HIPAA, GDPR) related to medical devices is a plus.
Previous hands-on software development experience is a plus.
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