Project Manager

Company Overview

SI-BONE, a publicly traded medical technology innovator specializing in minimally invasive sacropelvic solutions, is driven by the mission to enhance patient outcomes and establish global leadership in recognition and treatment of sacropelvic conditions through innovation and advocacy.

Position Summary

We are hiring a Project Manager or Senior Project Manager based in Santa Clara, CA, offering a remote working arrangement with occasional travel (10-20%). The successful candidate will contribute to managing a growing portfolio of projects within our PMO, supporting system and process enhancements.

Core Responsibilities

• Reporting to the VP of PMO, oversee timelines and accountabilities for select projects.
• Collaborate with multiple functional teams to ensure projects remain organized and on schedule.
• Maintain compliance with global regulatory standards as defined in the SI-BONE Quality Manual.
• Uphold company ethics by acting honestly and in alignment with internal policies and applicable industry codes.
• Create, track, and manage project timelines across various initiatives, coordinating task assignments with the broader PMO team.
• Lead and participate in cross-functional meetings, including those outside standard engineering and design controls.
• Identify and communicate potential schedule obstacles, working to streamline projects in partnership with Quality Assurance to ensure regulatory compliance.
• Provide operational support as needed, including assistance with non-conformances, design alterations, and corrective actions.
• Develop and implement metrics and communication strategies to monitor and report team progress towards project commitments.
• Manage individual project commitments aligned with business goals and continuously evaluate timelines for potential risks and acceleration opportunities.
• Exercise authority to halt product or quality documentation shipment if non-compliance with key standards (FDA QSRs, ISO 13485, ISO 14971) is suspected, reporting issues promptly.
• Actively support and adhere to the SI-BONE Quality System.

Desired Expertise and Attributes

• Strong commitment to support a rapidly growing company through engineering project leadership.
• Proven communication proficiency, both verbal and written.
• Basic interdisciplinary knowledge of medical device operations, including engineering, manufacturing, regulatory affairs, clinical, and quality assurance.
• Excellent analytical and interpretative skills.
• Experience in orthopedics highly valued; spine industry experience considered an advantage.
• Track record of successfully guiding initiatives with innovative and cost-effective approaches, followed by sustained product enhancements.
• Known for integrity, a strong work ethic, professionalism, and a proactive mindset.
• Ability to perceive organizational impact of projects and consistently seek comprehensive understanding to effectively communicate with team members.
• Familiarity with regulatory standards such as ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, and ISO 14971 appropriate for this role.

Qualifications and Experience

• Bachelor's degree in biomechanics, mechanical engineering, or related discipline preferred.
• Minimum of 4 years' project management experience within the medical device sector, ideally involving orthopedic spine-related products.
• Experience with design and change control processes is highly desirable.
• Demonstrated capability supporting R&D product development through launch, encompassing clinical, manufacturing, engineering, IT, and operations functions.
• Competence in MS Project and project schedule management.

Compensation and Additional Notes

Salary ranges reflect role and experience: $117,000-$130,000 for Project Manager level, and $150,000-$170,000 for Senior Project Manager, with additional bonuses and stock options possible. These figures consider multiple factors including expertise, certifications, and business impact.

Note: The iFuse Implant System carries inherent risks and may not be suitable for all patients. More details can be found directly from company resources.

Warning Against Recruitment Scams: SI-BONE cautions candidates regarding fake recruitment attempts that use our name and identity. All recruitment is conducted through official company channels with secure video interviews. Payments or check cashing requests are never part of our hiring process. Communication will come exclusively from official @si-bone.com emails.

If you suspect fraudulent activity, please report it following guidance from the Cybersecurity & Infrastructure Security Agency.