NPI Project Manager

SI-BONE•San Jose, CA

1d•Onsite

About The Position

SI-BONE is seeking a highly analytical and detail-oriented NPI Project Manager to support its growing portfolio of medical-device initiatives. The role leads new product introduction, product enhancement, and non-standard product projects, while helping continuously improve systems and processes. The position is based in San Jose, California, with occasional travel of 10–20%, and reports to the Associate Director, NPI Program Management. The Project Manager works across functional departments and with Product Management, Product Marketing, management, Quality, and other stakeholders to plan and deliver projects that meet company objectives. Responsibilities span early-stage planning and business cases through project execution and launch, including scope, timelines, resources, budgets, risk management, cross-functional coordination, and communication with leadership. The role also supports medical-device design and development, verification and validation planning, product support, and quality-related activities. The employee must conduct company business ethically and in compliance with applicable laws, regulations, company policies, and worldwide regulatory requirements. The role includes responsibility and authority to report suspected non-compliance and, when appropriate, to hold products or Quality documentation from shipment or further processing in potential cases of non-compliance.

Requirements

Bachelor’s degree or higher in an engineering or technical field.
At least 5 years of project/program management experience.
At least 5 years serving currently or recently as a project manager for a high-growth medical-device organization marketing products to a medical specialty practice.
Experience managing successful engineering projects through innovative engineering solutions and cost-effective manufacturing, followed by product support and improvement.
Deep understanding of medical-device design controls and commitment to quality.
Working cross-disciplinary understanding of medical-device business functions, including engineering, manufacturing, operations, R&D, clinical, regulatory, and quality assurance.
Knowledge of applicable regulations and standards, such as ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, and ISO 14971, as needed for the job.
Expertise in Microsoft Project and/or similar project-management software.
Excellent reading, writing, and analytical skills.
Effective communication and ability to work well with coworkers, physicians, and leadership.
Ability to take ownership of projects and understand and communicate their impacts across the organization.
Professional, proactive attitude; high integrity, sound character, strong work ethic, and passion to succeed.
Ability to ask questions to understand project details and communicate them to team members.
Ability to perform responsibilities in compliance with applicable regulatory requirements, company policies, and ethical standards.

Nice To Haves

Experience in orthopedics is highly desired.
Spine experience is a plus.

Responsibilities

Manage key NPI, product enhancement, and non-standard product initiatives with limited supervision.
Create and manage timelines for multiple initiatives and coordinate projects within assigned programs.
Work across functional departments and with Product Management to strategize, implement, and prioritize initiatives that meet company objectives.
Assign, coordinate, and assist with project deliverables from initiation through launch, including leading cross-functional meetings.
Work with management and Product Marketing to establish early-stage plans, including business cases, project scope, resourcing, and budgeting.
Identify, analyze, communicate, and address project risks and opportunities; escalate issues to organizational leadership when appropriate.
Facilitate solutions-based discussions, build stakeholder consensus, and communicate key decisions to leadership.
Streamline project activities while working closely with Quality to maintain compliance.
Create and implement metrics and communications to track and communicate commitments for scope, plans, and resources.
Manage assigned projects and make commitments to achieve specific business goals and objectives.
Evaluate project timelines proactively to identify hurdles and opportunities to accelerate work.
Assist coworkers with project tasks as needed.
Support design and development of medical instrumentation, equipment, and procedures using engineering principles.
Assist in evaluating product safety, efficiency, and effectiveness, and in verification and validation planning.
Assist with non-conformances, design changes, CAPAs, and related activities as needed.
Report suspected violations, unethical behavior, or potential regulatory non-compliance to Quality and/or Regulatory and management; hold products or Quality documentation from shipment or further processing when authorized and necessary.