Required

• Support and guide teams in Agile/Scrum planning, including estimation, scheduling, and delivery of committed tasks.

• Identify and capture user needs for digital applications, translating them into functional and non-functional requirements.

• Contribute to establishing robust system and software architectures for digital health applications, ensuring alignment with design inputs and quality standards.

• Write, maintain, and own software requirements/user stories in compliance with Quality Management Systems (QMS) and regulatory frameworks.

• Work with requirements and risk management tools to ensure traceability and compliance throughout the development lifecycle.

• Collaborate with engineering, QA, cybersecurity, and regulatory teams to deliver safe, connected medical products.

• Bachelor’s degree in Engineering (Software, Systems, Electrical, or similar) with 5+ years of experience, or Master’s degree with 3+ years.

• Ability to work on-site, 5 days/week at the San Diego office.

• Hands-on experience in requirements management, risk management, and Agile development, including backlog creation and maintenance.

• Strong documentation skills and exposure to a regulated industry (FDA/ISO).

• Proven experience with regulated products or connected systems in the medical devices/biotech industry (preferred).

• Familiarity with IoT solutions and connected architectures (preferred).

• Knowledge of medical device cybersecurity design paradigms (a plus).

• Experience with cloud-based digital applications (SaaS/PaaS/IaaS) using AWS/Azure or similar CSPs (preferred).

• Excellent oral and written communication skills.