Carlsmed's software systems need to be led by a Software Solutions Owner with strong clinical knowledge of spine surgery to gather, define, and prioritize requirements, ensuring the software platforms deliver maximum value for surgeons, patients, and the business.
Requirements
- Experience with Agile/Scrum tools such as Jira, Azure DevOps, or Rally for backlog and sprint management.
- Proficiency in requirements and documentation platforms such as Confluence or Jama.
- Understanding of CI/CD pipelines and DevOps environments (TeamCity, GitHub, Azure DevOps) to align with engineering workflows.
- Awareness of cloud technologies (AWS, Azure, or GCP) and their impact on product design and delivery.
- Hands-on experience with Agile/Scrum methodologies and backlog ownership.
- Solid understanding of FDA 21 CFR Part 11, ISO 13485, IEC 62304, and related medical device standards.
- Detail-oriented mindset with proven ability to write clear, testable, and traceable requirements.
Responsibilities
- Conduct discovery sessions with internal and external customers to translate insights into clear, testable software requirements and user stories.
- Maintain and own the product backlog; define acceptance criteria and prioritize features aligned with business goals and regulatory compliance.
- Develop and maintain a multi-year software roadmap, balancing innovation, clinical impact, and regulatory requirements.
- Collaborate with cross-functional engineering teams (software and hardware) to ensure seamless execution of requirements.
- Support software V&V activities and contribute to design history files (DHFs), risk management, and other FDA/ISO compliance documentation.
- Champion Agile/Scrum practices across the team, including backlog grooming, sprint planning, and review sessions.
- Serve as the voice of the customer and clinical advocate in technical discussions.
Other
- Strong clinical knowledge of spine surgery.
- 7+ years of experience as a Product Owner, Requirements Engineer, or Business Analyst in a medical device or healthcare software environment.
- Clinical knowledge of spine surgery, imaging, and surgical planning workflows.
- Demonstrated success defining and delivering multi-year roadmaps for complex software platforms.
- Strong communication skills with the ability to collaborate across technical and non-technical stakeholders.
