NPI Project Manager

SI-BONE, Inc•San Jose, CA

2d•$125,000 - $140,000

About The Position

SI-BONE is seeking a highly analytical and detail-oriented NPI Project Manager to lead projects across its growing portfolio and support continuous improvement of systems and processes. The role manages new product introduction, product enhancement, and non-standard product initiatives, coordinating cross-functional teams from project initiation through launch. The Project Manager partners with management, Product Management, Product Marketing, Quality, and other departments to plan and prioritize work, manage resources and budgets, monitor risks, and communicate progress and decisions. The position also supports medical device engineering and design and development, including safety and effectiveness evaluations, verification and validation planning, and product and quality activities such as non-conformances, design changes, and CAPAs. The role requires compliance with applicable worldwide regulatory requirements, company policies, and ethical standards, and includes authority to hold products or Quality documentation from shipment or further processing if potential regulatory non-compliance is identified.

Requirements

Minimum bachelor's degree in an engineering or technical field.
Minimum 5 years of experience in project or program management.
Currently or recently served as a project manager for a high-growth medical device organization whose products are marketed to a medical specialty practice, for a minimum of 5 years.
Demonstrated understanding of medical device design controls and commitment to quality.
Cross-disciplinary understanding of a medical device business, including engineering, manufacturing, operations, R&D, clinical, regulatory, and quality assurance.
Excellent reading, writing, communication, and analytical skills; ability to work effectively with coworkers, physicians, and leadership.
Expertise in Microsoft Project or similar project management software.
Knowledge of applicable regulations and standards, including ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, and ISO 14971, as needed for the job.
Track record of managing successful engineering projects through innovative engineering solutions and cost-effective manufacturing, followed by product support and improvement.
High integrity, sound character, strong work ethic, and a professional, can-do attitude.
Ability to take ownership of projects, understand and communicate their organizational impacts, and ask questions to understand and explain project details.

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, coordinating and delegating work across projects.
Assign, coordinate, and assist with deliverables from project initiation through launch, including leading cross-functional meetings.
Work with management and Product Marketing to establish early-stage project plans, business cases, project scope, resources, and budgets.
Identify, analyze, communicate, and address project risks; escalate issues to organizational leadership when appropriate.
Guide solutions-based discussions, build stakeholder consensus, and communicate key decisions to leadership.
Streamline projects and activities while working with Quality to ensure compliance.
Create and implement metrics and communications to help ensure team commitments for scope, plans, and resources are met and communicated on time.
Manage assigned portfolio projects and make commitments to meet business goals and objectives.
Evaluate timelines proactively to identify upcoming hurdles and opportunities to accelerate projects.
Assist coworkers with project tasks as needed.
Support the design and development of medical instrumentation, equipment, and procedures using engineering principles.
Assist with evaluating product safety, efficiency, and effectiveness, and with verification and validation planning.
Assist with non-conformances, design changes, CAPAs, and related activities as needed.
Perform duties in compliance with applicable worldwide regulatory requirements and SI-BONE policies and ethical standards.
Report suspected violations or unethical behavior; report potential non-compliance with applicable standards or regulations to Quality and/or Regulatory and management.
Hold products or Quality documentation from shipment or further processing when potential non-compliance with applicable standards or regulations is identified.