Project Manager - New Product Introduction (NPI)

Why Orthofix? Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further. POSITION SUMMARY: We are seeking a highly capable Project Manager - New Product Introduction (NPI) to own the end‑to‑end project lifecycle for new product introductions, from concept through launch and post‑launch execution. This is an individual contributor role with direct accountability for project execution, planning, and cross‑functional coordination. The Project Manager is responsible for building and maintaining robust, integrated project plans, proactively removing roadblocks, and ensuring cross‑functional alignment to deliver high‑quality products on time and on strategy. The role requires the ability to manage multiple NPI projects concurrently, balancing priorities, resources, and timelines across a dynamic portfolio. This position is part of the Product Portfolio Management & Execution team and will primarily support the Orthofix Therapeutic Solutions business unit, with the flexibility to support other areas of the business as needed. POSITION SCOPE: Manage multiple NPI projects concurrently, balancing priorities, resources, timelines, and cross‑functional dependencies across the active portfolio Own the full NPI project lifecycle, including initiation, planning, execution, monitoring/control, and closeout Act as the single point of accountability for project execution, coordination, and communication Translate product strategy and business objectives into clear project scope, timelines, milestones, and deliverables Drive cross‑functional alignment across R&D, Regulatory, Quality, Operations, Supply Chain, Marketing, Finance, Clinical, and Sales Ensure adherence to internal governance, quality systems, and portfolio priorities Support adjacent or enterprise‑level projects as required to meet broader organizational objectives DUTIES AND RESPONSIBILITIES (essential functions of position): Develop and maintain integrated NPI project schedules, including cross‑functional dependencies, critical paths, and key decision points Lead and facilitate cross‑functional core team meetings and milestone reviews Stakeholder management Proactively identify project risks, issues, and constraints; develop and execute mitigation and contingency plans Drive timely decision‑making by escalating issues and trade‑offs with clear recommendations Provide clear, concise, and timely project status updates to stakeholders and leadership Track and report overall project health, including schedule, scope, risks, and key milestones Ensure project documentation, deliverables, and decisions are captured and maintained as a single source of truth Partner with Product Portfolio Management to support prioritization, resource alignment, and portfolio trade‑off decisions Capture lessons learned and contribute to continuous improvement of NPI execution practices ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS: Bachelor's degree in Engineering, Business, Life Sciences, or a related field 4-6 years of demonstrated experience owning end‑to‑end project management for complex, cross‑functional initiatives Strong knowledge of structured project management methodologies and execution best practices Excellent communication, facilitation, and interpersonal skills, with the ability to influence without direct authority Proven ability to anticipate issues, remove roadblocks, and drive execution in fast‑paced environments Strong organizational skills, including the ability to manage multiple priorities and dependencies PREFERRED SKILLS, EXPERIENCE AND QUALIFICATIONS: Experience using Smartsheet for project planning, scheduling, and cross‑functional collaboration Project Management Professional (PMP) certification Experience managing medical device product development in regulated environments Experience with Class III medical devices Familiarity with FDA design controls, phase‑gate development processes, and product launch readiness PHYSICAL DEMANDS AND WORK CONDITIONS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This role is on‑site at the Lewisville, TX headquarters. Regular in‑person collaboration is required to support cross‑functional NPI execution. Periodic travel (up to 10%) may include trips to meet with vendors, manage joint development partnerships, engage customers including surgeons, observe surgical procedures, interface with satellite corporate facilities, participate in workshops. Eyesight should be correctable to standard passing level. Sitting, standing, bending frequently. Able to function in operating room and lab environments. Utilize computer system ‑ 70% daily. Phone usage - daily. DISCLAIMER The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status. We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment. Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide. Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company's global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil. Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients' lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.