Software Solutions Owner bei Carlsmed

Position Description

We are seeking a Software Solutions Owner with strong clinical knowledge of spine surgery to lead the gathering, definition, and prioritization of requirements for Carlsmed’s software systems. This role bridges clinical, commercial, and technical perspectives to ensure our software platforms deliver maximum value for surgeons, patients, and the business. You will collaborate with marketing, internal and external customers, and cross-functional engineering teams to shape the multi-year software roadmap.

This role requires hands-on experience in Scrum product ownership, deep understanding of FDA-regulated medical device software development, and the ability to translate clinical and business needs into actionable requirements for engineering teams.

Key Responsibilities

• Partner with marketing, clinical affairs, surgeons, and internal stakeholders to gather and prioritize user needs, market trends, and business opportunities.
• 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.
• Monitor post-market feedback, regulatory updates, and competitive activity to inform roadmap updates.

Qualifications

• Bachelor’s or Master’s degree in Biomedical Engineering, Computer Science, or related field.
• 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.

• 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.

• Demonstrated success defining and delivering multi-year roadmaps for complex software platforms.
• 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.
• Strong communication skills with the ability to collaborate across technical and non-technical stakeholders.
• Detail-oriented mindset with proven ability to write clear, testable, and traceable requirements.

Equal Opportunity Employer

Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay rate is between $165,000 and $185,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.