Siboneinc
Software Product Manager
Remote - USA. Posted a month ago
The role
The Software Product Manager will support upstream development and commercialization for a software solution in the spinopelvic portfolio. This role involves UX/UI strategy, software application design, and software verification and validation.
What you will do
- Collaborate with product development and engineering teams on software product development
- Lead strategy for UX/UI and software application design
- Provide input on strategy for gathering and synthesizing user requirements
- Work cross-functionally with engineering, regulatory teams, and design surgeons
- Collaborate with commercial and strategy teams to identify market opportunities and growth initiatives
- Support the SI-BONE Quality System
- Author and maintain user requirements, product requirements, and user stories
- Manage the 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 and documentation
Required qualifications
- 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
- Hands-on experience with pre-operative planning, surgical navigation, or 3D image-based software
- Working knowledge of Software as a Medical Device (SaMD) development and standards including IEC 62304, IEC 62366, ISO 14971, and FDA guidance
- Familiarity with software verification and validation in a design-controlled environment
- Experience contributing to regulatory strategy for software
- Experience managing external software development partners or contract engineering firms
- Ability to translate surgeon and OR workflow observations into user needs, requirements, and wireframes
- Data literacy to define analytics, telemetry, and success metrics
- Highly skilled with Microsoft Office Suite, particularly Word, PowerPoint, and Excel
- Able to 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)
Nice to have
- experience in the medical device industry
- experience in spine
About the company
SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions.