Remote Part-Time Software Product Manager – Medical SaMD

OpenKrill; United States; Remoto; USD 90.000 - 130.000; Part-time

Descrizione del lavoro

SI-BONE seeks a Software Product Manager (Independent Contractor) for a remote, part-time role in the United States. This position focuses on upstream product management for a pre-operative planning software within the spinopelvic portfolio, collaborating with UX/UI, engineering, and clinical teams.

The role requires experience with SaMD development, regulatory strategy, and agile processes, and involves guiding requirements, user research, and go-to-market activities with cross-functional

Competenze

• Bachelor's degree with 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.
• Experience in medical device, healthcare or another regulated field strongly desired.
• 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 SaMD development standards (IEC 62304, IEC 62366, ISO 14971) and FDA premarket software guidance.
• Experience contributing to regulatory strategy for software, including 510(k)/De Novo pathways, in partnership with Regulatory and Quality.
• Able to operate in an agile, iterative development cadence while meeting design control and documentation requirements.

Mansioni

• Collaborate with product development and engineering to provide input on software product management.
• 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 go-to-market planning.
• 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.
• Partner with Regulatory and Quality on software risk analysis and documentation for submission.
• Review verification and validation protocols from a user‑needs perspective and support human factors validation.
• Establish and document software product management practices.

Conoscenze

DICOM workflows

Surgical planning

Agile development

User requirements analysis

Stakeholder collaboration

Analytics & metrics

Formazione

Bachelor's Degree

Master’s Degree

Strumenti

SaMD development tools

CAD/3D imaging tools

Descrizione del lavoro

SI-BONE seeks a Software Product Manager (Independent Contractor) for a remote, part-time role in the United States. This position focuses on upstream product management for a pre-operative planning software within the spinopelvic portfolio, collaborating with UX/UI, engineering, and clinical teams.

The role requires experience with SaMD development, regulatory strategy, and agile processes, and involves guiding requirements, user research, and go-to-market activities with cross-functional