Director, Product Development

Globus Medical•Audubon, PA

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. About Us : At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary : The Director, Product Development oversees the design and development of medical devices. This effort includes the investigation and evaluation of existing medical device technologies and the conceptualization of new methodologies, materials, machines, processes, or products. The Director, Product Development also leads the development of new concepts from initial design to market release, managing feasibility studies of the design to determine if capable of functionality as intended. Essential Functions : Collaborates with senior management to establish strategic plans and objectives Cascades functional strategy and contributes to the development of organizational policies Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people Makes decisions on implementation and ensures operational effectiveness Ensures budgets and schedules meet corporate requirements Oversees staff in the conceptualization, design, manufacturing and launch of products Works on complex issues where problems are not clearly identified and where fundamental principles do not fully apply Accountable for how actions impact function or department budget Monitors documentation maintenance throughout all phases of research and development Represents company and function during agency audits Establishes process capabilities and baseline performance through process studies Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Requirements

Bachelor’s Degree with 7-10 years of related experience; or Master’s Degree and 5-7 years of experience
Excellent verbal and written communication skills
Advanced project management skills
Experience with new product introduction and lifecycle management
Advanced critical thinking and problems-solving skills
Experience working in a highly technical and regulated industry
Proficiency in using Microsoft Office products
Familiarity with the FDA 21 CFR, 510(k) process, and relevant standards, such as IEC 60601, 62304, 62366
Ability to function well under tight timelines and pressure
Experience with medical capital electro-mechanical systems
Ability to work with limited supervision
Ability to travel up to 20% of the time

Responsibilities

Collaborates with senior management to establish strategic plans and objectives
Cascades functional strategy and contributes to the development of organizational policies
Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
Makes decisions on implementation and ensures operational effectiveness
Ensures budgets and schedules meet corporate requirements
Oversees staff in the conceptualization, design, manufacturing and launch of products
Works on complex issues where problems are not clearly identified and where fundamental principles do not fully apply
Accountable for how actions impact function or department budget
Monitors documentation maintenance throughout all phases of research and development
Represents company and function during agency audits
Establishes process capabilities and baseline performance through process studies
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties