Software Product Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the upstream development and potential commercialization of software for SI-BONE’s spinopelvic portfolio.

• Contribute insights on software product development alongside product development and engineering teams.

• Lead the strategy for UX/UI and software application design.

• Aid in gathering and synthesizing user requirements.

• Collaborate across functions with engineering, regulatory teams, and design surgeons to create and launch products.

• Identify market opportunities, potential partnerships, and growth initiatives; perform market research and assist in business case development and go-to-market strategies.

• Support the SI-BONE Quality System.

• Draft and uphold user requirements, product requirements, and user stories; manage backlog and release scope with the engineering team.

• Organize and facilitate voice-of-customer and usability activities with surgeons and OR staff.

• Collaborate with Regulatory and Quality teams on software risk analysis, intended use and indications, and submission documents.

• Evaluate verification and validation protocols and results; assist in human factors validation.

• Establish software product management practices, templates, review cadences, and decision records.

• Mentor and enhance the skills of SI-BONE product managers regarding software-specific practices.

⛳️ Requirements

• Bachelor's Degree with a minimum of 2–4 years of experience, or a Master’s Degree.

• Over 2 years of experience in software product management, product marketing, or sales support.

• Practical experience with pre-operative planning, surgical navigation, or 3D image-based software, including DICOM workflows, CT/MRI segmentation, and implant templating or measurement tools.

• Knowledge of Software as a Medical Device (SaMD) development and familiarity with IEC 62304, IEC 62366, ISO 14971, and FDA premarket software and cybersecurity guidance.

• Experience with software verification and validation in a design-controlled environment, which includes requirements traceability, test protocol reviews, defect triage, and design history file documentation.

• Involvement in regulatory strategies for software, including 510(k)/De Novo pathways, clinical decision support versus device determinations, and considerations for AI/ML-enabled devices.

• Capability to function in an agile, iterative development environment while adhering to design control and documentation requirements.

• Experience managing external software development partners or contract engineering firms.

• Proven experience conducting voice-of-customer interviews, formative usability studies, and design surgeon panels.

• Data literacy adequate to define analytics, telemetry, and success metrics for clinical software products.

• Ability to handle multiple tasks and adapt to changing priorities within tight timelines.

• Demonstrated self-starter who can work independently and prioritize time and resources effectively.

• Strong writing skills for creating product requirements documents, user requirement specifications, roadmaps, and decision memos.

• Credibility to influence engineering, regulatory, and commercial stakeholders without direct authority.

• Highly proficient in Microsoft Office Suite, especially Word, PowerPoint, and Excel.

• Familiarity with relevant regulations and standards, including ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, and ISO 14971.

• Ability to occasionally lift and/or move up to 22 pounds.

🏝️ Benefits

• Part-time independent contractor (consultant) arrangement.

• Remote work opportunity within the USA.

• Up to 1–4 trips per year for R&D laboratory support.