Business Analyst

JOB SUMMARY: As a part of Ambulatory Monitoring and Diagnostics Heart, R&D organization and a Technical Business Analyst, you'll be a part of highly collaborative, cross-functional Scrum teams within the ECG Solutions group. You will help enable teams in their continued journey through SAFe, to think creatively, take risks and consider the "What if... scenario all the while ensuring that the squad is fully functional, productive, and focused on sprint and PI goals.
ROLES & RESPONSIBILITIES:

• Collaborate with cross-functional teams, including product managers, systems engineers, software engineers and UX designer teams, to gather and document software requirements.
• Ensure traceability of requirements throughout the software development lifecycle, linking them to design, implementation, and testing phases.
• Ensure all software requirements comply with relevant regulatory standards, including IEC-62304.
• 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.
• Stay up-to-date with the latest regulatory standards and industry best practices related to software as a medical device.

MINIMUM QUALIFICATIONS:

• 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.
• Familiarity with software development processes, particularly within an Agile framework.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work collaboratively with cross-functional teams and manage multiple priorities.
• Strong knowledge of IEC-62304, FDA guidelines, ISO 14971, and other relevant standards for medical device software development is a plus.
• 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.