Software Product Manager

The Software Product Manager will play a key role in the upstream development and potential commercialization efforts of a software solution for SI-BONE’s spinopelvic portfolio. This individual will engage primarily in upstream product management activities to support UX/UI, software application design, and software verification and validation.

Working closely with cross-functional teams, and in a consultative capacity alongside SI-BONE’s existing product managers, the Software Product Manager will support the definition and development of a pre-operative planning application and will help ensure the continued success of SI-BONE’s emerging product lines. The ideal candidate is a proactive, high-energy contributor who brings passion, curiosity, and a hands-on approach to every aspect of the product development process.

General Responsibilities:

The Software Product Manager must always act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual.

Specific Responsibilities and Skills:

• Collaborate with SI-BONE’s product development and engineering team to provide input on software product development.
• Lead strategy surrounding UX/UI and software application design.
• Provide input on strategy for gathering and synthesizing user requirements and inputs.
• Work cross-functionally with engineering and regulatory teams and design surgeons to develop and launch new products.
• Collaborate with commercial and strategy teams to identify new market opportunities, partnerships, and growth initiatives aligned with the product roadmap. Conduct market research, support business case development, and contribute to go-to-market planning for new products or enhancements.
• Support the SI-BONE Quality System.
• Author and maintain user requirements, product requirements, and user stories, and manage the backlog and release scope with engineering.
• Plan and run voice-of-customer and usability activities with surgeons and OR staff, and translate findings into design inputs and workflow decisions.
• Partner with Regulatory and Quality on software risk analysis, intended use and indications statements, and the software documentation required for submission.
• Review verification and validation protocols and results from a user-needs perspective, and support human factors validation.
• Establish and document software product management practices — templates, review cadences, and decision records — that SI-BONE product managers can carry forward independently.

Knowledge, Education, and Experience:

• A Bachelor’s Degree with a minimum of 2-4 years of experience; or a Master’s Degree.
• 2+ years of software product management or product marketing or sales support experience, ideally in the medical device industry (a plus if in spine).
• Experience in medical device, healthcare, or another regulated field strongly desired (a plus if in spine).
• Hands-on experience with pre-operative planning, surgical navigation, or 3D image-based software — including DICOM workflows, CT/MRI segmentation, and implant templating or measurement tools.
• A working knowledge of Software as a Medical Device (SaMD) development and the standards that govern it, including IEC 62304 software lifecycle, IEC 62366 usability engineering, ISO 14971 risk management as applied to software, and FDA premarket software and cybersecurity guidance.
• Familiarity with software verification and validation in a design-controlled environment: requirements traceability, test protocol review, defect triage, and design history file documentation.
• Experience contributing to regulatory strategy for software, including 510(k)/De Novo pathways, clinical decision support versus device determinations, and AI/ML-enabled device considerations, in partnership with Regulatory and Quality.
• Ability to operate in an agile, iterative development cadence while meeting design control and documentation requirements.
• Experience managing external software development partners or contract engineering firms — scoping statements of work, reviewing deliverables, and holding vendors to schedule and quality commitments.
• Ability to translate surgeon and OR workflow observations into user needs, requirements, and wireframes; direct experience running voice-of-customer interviews, formative usability studies, and design surgeon panels.
• Data literacy sufficient to define analytics, telemetry, and success metrics for a clinical software product.
• Able to work in a high-performing team environment and possess a demonstrated ability to multi-task and accommodate changing priorities within compressed timelines.
• Demonstrated self-starter, with ability to work independently and prioritize time and resources.
• Proven track record of success and teamwork, with a strong dedication to excellence and customer satisfaction.
• Consultative operating style: able to embed with an existing product team, ramp quickly with minimal onboarding, and add value without displacing internal ownership.
• Willingness to coach and upskill SI-BONE product managers on software-specific practices, leaving behind repeatable templates and processes.
• Strong written deliverable discipline — product requirements documents, user requirement specifications, roadmaps, and decision memos that stand on their own for reviewers who were not in the room.
• Comfortable with ambiguity; able to frame a problem and recommend a path forward where none has been defined.
• Credibility to influence engineering, regulatory, and commercial stakeholders without direct authority, and sound judgment on when to escalate versus decide.
• Highly skilled with Microsoft Office Suite, particularly Word, PowerPoint, and Excel.
• The employee must occasionally lift and/or move up to 22 pounds.
• Knowledge and familiarity of applicable regulations/standards (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function.