Project Manager

SI-BONE, Inc•San Jose, CA

11h•$117,000 - $130,000•Onsite

About The Position

SI-BONE is seeking a Project Manager to lead cross-functional projects for products already on the market, as well as the business systems and quality programs that support them. The Project Manager will serve as the core team leader, aligning functions and suppliers around a shared plan and driving on-time, high-quality delivery. The role is based in San Jose, California, with occasional travel of 10–20%. It is suited to someone who can thrive in a high-growth environment, understands the rigor of medical-device design and change controls, and can move between technical detail and business priorities. The Project Manager owns program timelines, budgets, and deliverables from initiation through release and closure. Responsibilities include maintaining integrated plans, coordinating teams, managing concurrent projects and external partners, tracking and communicating program performance, and addressing risks and issues. The role also supports product changes, business-system releases, quality programs, regulatory assessments, and audit readiness in accordance with applicable medical-device requirements.

Requirements

Bachelor's degree in a related discipline.
At least 5 years of experience as an engineer or project manager in the medical device industry.
Track record of delivering product and system changes under formal change control.
Working knowledge of design controls, change control, risk management, and the medical-device product lifecycle.
Cross-disciplinary understanding of engineering, manufacturing, operations, R&D, IT, clinical, regulatory, and quality functions.
Experience running several concurrent cross-functional projects against firm deadlines.
Strong communication skills and ability to work effectively with coworkers, surgeons, clinicians, distributor representatives, suppliers, and implementation partners.

Nice To Haves

Experience in orthopedics; spine or sacropelvic experience is a strong plus.
Experience in a high-growth medical-device company serving a specialty physician audience.
History of innovative engineering solutions, cost-effective manufacturing, and ongoing product improvement after launch.
Experience with ERP or other regulated business-system implementations, including computer system validation.
Experience managing suppliers or contract manufacturers.
PMP or equivalent project-management certification.
Proficiency with project-management tools such as MS Project or Smartsheet.

Responsibilities

Own program timelines, budgets, and deliverables from initiation through release and closure, including design-control and change-control milestones.
Lead core teams by defining program scope, securing cross-functional alignment, and ensuring rigorous, timely delivery.
Build and maintain integrated project plans, identifying critical paths, dependencies, and cross-functional resource needs.
Assess timelines proactively, anticipate risks and obstacles, develop mitigation plans, and identify opportunities to accelerate delivery.
Lead core team meetings and additional cross-functional working sessions as needed beyond standing engineering and design-control reviews.
Lead cross-functional troubleshooting and root-cause efforts for on-market products, partnering with Quality, Manufacturing, and Engineering to drive resolution.
Develop and implement program metrics, dashboards, and status reporting to track and clearly communicate commitments on scope, schedule, and resources.
Escalate issues and tradeoff decisions to leadership with clear options and recommendations.
Manage suppliers, contract manufacturers, and implementation partners against agreed scope, cost, and dates.
Manage several concurrent projects and meet commitments tied to specific business goals.
Ensure product changes, business-system releases, and quality programs meet objectives for performance, quality, cost, and schedule.
Consider program effects on manufacturing capacity, supply chain, business systems, sales training, and surgeon education.
Support team members directly on project tasks when needed to keep work moving.
Ensure programs follow design-control and change-control requirements under 21 CFR Part 820 (QMSR), ISO 13485, and ISO 14971 risk management.
Partner with Regulatory Affairs to plan and support regulatory assessments and submissions for product changes, such as 510(k) submissions, and with Quality to maintain complete, audit-ready Design History Files.
Support CAPA, nonconformance, and audit readiness across projects.