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SI-BONE, Inc. Verified

Project Manager

RemoteRemoteFull Time$117,000–$130,000 /yrPosted 15 days ago

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Required skills

  • medical device
  • change control
  • 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • risk management
  • CAPA
  • nonconformance
  • audit readiness
  • product lifecycle

Nice to have

  • orthopedics
  • spine
  • sacropelvic
  • high-growth
  • specialty physician
  • innovative engineering

Role summary

SI-BONE is seeking a Project Manager in San Jose, CA, to lead cross-functional projects for existing products and supporting business systems and quality programs. This role involves acting as a core team leader, aligning various departments (Engineering, R&D, Manufacturing, Operations, Quality, Regulatory, IT, Finance, Clinical, Marketing) around project plans to ensure timely, high-quality delivery. The ideal candidate will have 5+ years of experience in the medical device industry, a strong understanding of design and change controls, and the ability to manage multiple concurrent projects. Responsibilities include owning program timelines, budgets, and deliverables, identifying risks, developing mitigation plans, and ensuring compliance with medical device regulations like 21 CFR Part 820 and ISO 13485. Proficiency in project management tools and experience with ERP implementations are preferred.

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.

Project Manager

Location: San Jose, CA

Travel: Occasional -- 10-20%

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:

    We are seeking a Project Manager that will lead cross-functional projects for products already on the market, and for the business systems and quality programs that support them. The Project Manager will act as the core team leader for your projects. They will align Engineering, R&D, Manufacturing, Operations, Quality, Regulatory, IT, Finance, Clinical, Marketing and suppliers around a shared plan and drive it to on-time, high-quality delivery.

    The ideal candidate will thrive in a high-growth environment, understand the rigor of medical device design and change controls, and move easily between technical detail and business priorities.

    Specific Responsibilities and Skills:

  • Own program timelines, budgets, and deliverables from initiation through release and closure, including design control and change control milestones.
  • Serve as core team leader: define program scope, secure cross-functional alignment, and make sure delivery is both rigorous and timely.
  • Build and maintain integrated project plans, identifying the critical path, dependencies, and resource needs across functions.
  • Proactively assess timelines to anticipate risks and obstacles, develop mitigation plans, and identify opportunities to accelerate delivery.

    • Cross-Functional Coordination and Communication

  • Lead core team meetings and convene 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 closely with Quality, Manufacturing, and Engineering to drive resolution.
  • Develop and implement program metrics, dashboards, and status reporting so that team commitments (scope, schedule, resources) are tracked and communicated clearly to stakeholders and leadership.
  • 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.

    • Portfolio and Business Impact

  • Manage several projects at once, making and meeting commitments tied to specific business goals.
  • Ensure product changes, business system releases, and quality programs meet established objectives for performance, quality, cost, and schedule.
  • Consider how each program affects the broader organization, including manufacturing capacity, supply chain, business systems, sales training, and surgeon education.
  • Support team members directly on project tasks when needed to keep work moving.

    • Compliance and Quality

  • 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 (e.g., 510(k)) and with Quality to maintain complete, audit-ready Design History Files.
  • Support CAPA, nonconformance, and audit readiness across your projects.

    • Knowledge, Education, & Experience:

  • Bachelor's degree in related discipline.
  • 2-4 years of experience as an engineer or project manager in the medical device industry.
  • A 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 projects across functions against firm deadlines.
  • Strong communication skills, with the ability to work effectively with coworkers, surgeons, clinicians, distributor representatives, suppliers, and implementation partners.

    • Preferred Experience:

  • Experience in orthopedics; spine or sacropelvic experience is a strong plus.
  • Experience in a high-growth medical device company whose products serve a specialty physician audience.
  • A 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 (e.g., MS Project, Smartsheet).

    • Salary range: $117,000- $130,000. The compensation range for this position is specific to the location, experience and level and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.

    Supplemental pay: bonus and stock

    There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain “@si-bone.com” to communicate with candidates.If you believe you’ve been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.

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