Software Product Manager

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $200 - $280 / hour

⏱ Part Time

🟢 Junior

🟡 Mid-level

✅ Product Manager

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SI-BONE

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

Healthcare • Manufacturing • Healthcare Insurance

SI-BONE is a medical technology company that specializes in the diagnosis and treatment of sacroiliac (SI) joint disorders, a significant cause of chronic low back pain. The company is best known for its iFuse Implant System, a minimally invasive surgical device designed to stabilize and fuse the SI joint. SI-BONE provides a range of resources for patients, healthcare providers, and investors, including educational materials, clinical evidence, patient stories, and webinars. Their solutions aim to reduce pain and enhance mobility in patients suffering from SI joint dysfunction.

📋 Description

• Support upstream development and potential commercialization of software for SI-BONE’s spinopelvic portfolio • Provide input on software product development with product development and engineering teams • Lead UX/UI and software application design strategy • Support user-requirements gathering and synthesis • Work cross-functionally with engineering, regulatory teams, and design surgeons to develop and launch products • Identify market opportunities, partnerships, and growth initiatives; conduct market research and support business cases and go-to-market planning • Support the SI-BONE Quality System • Author and maintain user requirements, product requirements, and user stories; manage backlog and release scope with engineering • Plan and run voice-of-customer and usability activities with surgeons and OR staff • Partner with Regulatory and Quality on software risk analysis, intended use and indications, and submission documentation • Review verification and validation protocols and results; support human factors validation • Establish software product management practices, templates, review cadences, and decision records • Coach and upskill SI-BONE product managers on software-specific practices

🎯 Requirements

• Bachelor's Degree with minimum of 2–4 years of experience; or Master’s Degree • 2+ years of software product management, product marketing, or sales support experience • 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 IEC 62304, IEC 62366, ISO 14971, and FDA premarket software and cybersecurity guidance • Familiarity with software verification and validation in a design-controlled environment, including 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 • 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 • 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 • Ability to multitask and accommodate changing priorities within compressed timelines • Demonstrated self-starter able to work independently and prioritize time and resources • Strong written deliverable discipline for product requirements documents, user requirement specifications, roadmaps, and decision memos • Credibility to influence engineering, regulatory, and commercial stakeholders without direct authority • Highly skilled with Microsoft Office Suite, particularly Word, PowerPoint, and Excel • Knowledge of applicable regulations/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 in the USA • Up to 1–4 trips per year for R&D laboratory support