Business yst III

Business Analyst III

12 Months

3721 Valley Centre DriveSan Diego CA

Description:

You are responsible for
Collaborate with crossfunctional 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 IEC62304.
Translate business and regulatory needs into detailed functional and nonfunctional 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 uptodate with the latest regulatory standards and industry best practices related to software as a medical device.


You are a part of
Ambulatory Monitoring and Diagnostics Heart R&D organization. As a Technical Business Analyst youll be a part of highly collaborative crossfunctional 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.

To succeed in this role youll need a customerfirst attitude and the following
Bachelors 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 nontechnical 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.
Excellent analytical problemsolving and communication skills.
Ability to work collaboratively with crossfunctional teams and manage multiple priorities.
Strong knowledge of IEC62304 FDA guidelines ISO 14971 and other relevant standards for medical device software development is a plus.
Certification in business analysis (e.g. CBAP PMIPBA) is a plus.
Understanding of cybersecurity principles and data privacy regulations (e.g. HIPAA GDPR) related to medical devices is a plus.
Previous handson software development experience is a plus.