Software Product Manager

About this role

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.

Job Title: Software Product Manager

Independent Contractor (Consultant) - Part-Time

Location: Remote (USA)

Travel: Up to 1-4 trips per year for R&D laboratory support

SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are:

• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly.

• Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo.

• Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

General Responsibilities:

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 and help identify and evaluate new opportunities to grow the company’s portfolio. 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.

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:

• Bachelor's Degree with minimum of 2-4 years of experience; or 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.

• 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…