Software Product Manager
Part-time, remote consultant role: a Software Product Manager advising a medical device company on upstream development of a pre-operative planning application — leading UX/UI and software design strategy, writing user/product requirements, running voice-of-customer and usability work, and supporting SaMD verification, validation, and regulatory documentation using DICOM/3D imaging workflows and s
- Compensation
- $200–$280 / hr
- Location
- Remote - USA
- Work setup
- Remote
- Seniority
- Not specified
- Employment
- Part time
- Experience
- 2+ years
- Category
- Product
- Posted
Skills
Must have
- Bachelor's Degree with minimum 2-4 years of experience; or Master's Degree
- 2+ years of software product management, product marketing, or sales support experience, ideally in medical device (spine a plus)
- Hands-on experience with pre-operative planning, surgical navigation, or 3D image-based software — DICOM workflows, CT/MRI segmentation, implant templating/measurement tools
- Working knowledge of SaMD development and governing standards: IEC 62304, IEC 62366, ISO 14971 (as applied to software), FDA premarket software and cybersecurity guidance
- Familiarity with software verification and validation in a design-controlled environment: requirements traceability, test protocol review, defect triage, design history file documentation
- Experience contributing to software regulatory strategy: 510(k)/De Novo pathways, clinical decision support vs device determinations, 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 (scoping SOWs, reviewing deliverables, holding vendors to schedule/quality)
- Ability to translate surgeon and OR workflow observations into user needs, requirements, and wireframes; experience running voice-of-customer interviews, formative usability studies, and design surgeo
- Data literacy sufficient to define analytics, telemetry, and success metrics for a clinical software product
- Ability to multi-task and accommodate changing priorities within compressed timelines in a high-performing team environment
- Demonstrated self-starter able to work independently and prioritize time and resources
- Consultative operating style: embed with existing product team, ramp quickly with minimal onboarding, add value without displacing internal ownership
- Willingness to coach and upskill SI-BONE product managers on software-specific practices, leaving repeatable templates and processes
- Strong written deliverable discipline: PRDs, user requirement specifications, roadmaps, decision memos
- Comfortable with ambiguity; able to frame a problem and recommend a path forward where none is defined
- Credibility to influence engineering, regulatory, and commercial stakeholders without direct authority
- Highly skilled with Microsoft Office Suite, particularly Word, PowerPoint, and Excel
- Ability to occasionally lift and/or move up to 22 pounds
- Knowledge and familiarity of applicable regulations/standards (ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971)
- Willingness to travel up to 1-4 trips per year for R&D laboratory support
Nice to have
- Experience in medical device, healthcare, or another regulated field strongly desired (spine a plus)
Full description
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-TimeLocation: 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.