Senior Director, Product Development

Globus Medical•Methuen, MA

22h

About The Position

Our enabling technology division is searching for an enthusiastic Senior Director of Product Development to lead our navigation and computer vision team. This leadership position will be responsible for planning, directing and implementing all aspects of the surgical navigation program within Globus Medical and set the standard for product development, research and innovation within the industry. The position will be hands-on and require an individual capable of creative, scalable and systematic product development with minimum supervision. Success in this role will require highly effective staff management as well as collaboration across multiple cross functional teams to achieve shared objectives related to new product design, sustaining efforts, manufacturing initiatives, and corrective actions. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced environment. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, flexibility and maturity.

Requirements

Bachelor’s Degree with 10+ years of related business experience required or Master’s degree with 7+ years of experience
Excellent oral and written communication skills
Experience in new product introduction, design control process and lifecycle management
Strong project management skills
Must be able to deliver results while working to tight timelines
Have the ability to resolve complex issues
Solid experience in a highly technical and regulated industry
Working knowledge of Windows, Microsoft Office, E-mail, and Microsoft Project
Ability to travel up to 10-20% of the time
Familiar with the FDA 21 CFR, 510(k) process, and relevant standards, such as IEC 60601, 62304, 62366.
Responsive problem solver in resolving customer issues and meeting customer requirements.
Ability to work under minimum supervision with a high degree of organizational, technical, and business competence.

Responsibilities

Successfully lead and manage the surgical navigation and computer vision product development program for Globus Medical
Lead, manage and develop the multi-disciplined product development team including electrical, mechanical, software, algorithms and systems engineering as well as product management
Focus on rapid new product introductions to establish Globus as the leader in safety and innovation in the industry
Manage department specific sustaining efforts and complaints to maintain product performance and quality in the market
Lead the project portfolio including driving discipline to Globus Medical’s product development process, following design controls and maintaining device design history files.
Develop and maintain the navigation and computer vision technology strategy and roadmap aligned to the Globus Medical’s corporate roadmap
Perform and maintain market analysis by each product segment to identify new product offerings and line extensions to ensure Globus has the best product offering in industry
Recruit, hire, and train employees to fill positions as they arise and maintain a high-performance department
Responsible for all Quality Compliance activities for products within department including complaint, CAPA, MDR, NCMR, and all relevant compliance activities
Work closely with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE & PMA submissions and approvals
Create policies and procedures and maintain compliance of department to ensure compliance with all worldwide regulatory bodies including the FDA
Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical Investigator Groups, surgeons, and sales force
Development of sound electrical, mechanical, software, pre-clinical, and clinical data of scientific merit on all technologies developed
Work closely with Director, Marketing to coordinate product and company marketing efforts
Work closely with VP, Corporate Development to ensure that Globus can attract and retain the best surgeons to serve on product development teams, surgeon boards, think tanks, podium speakers, etc.
Participate in management meetings on strategic initiatives and business planning
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 upholds 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.