Director, Product Development

Globus Medical Inc; Methuen (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Globus Medical seeks a Senior Director of Product Development to lead its navigation and computer vision program. You will direct a multi-disciplinary team, align development with the corporate roadmap, and drive design controls and regulatory milestones to deliver safe, innovative devices.

The role requires hands-on leadership in a fast-paced environment. The ideal candidate brings 10+ years in product development in a regulated medical device environment, strong project management, and proven

Qualifications

• Bachelor’s degree with 10+ years of related business experience or Master’s with 7+ years of experience.
• Experience in new product introduction, design control process and lifecycle management.
• Strong project management skills.
• Familiar with FDA 21 CFR, 510(k) processes and relevant standards (IEC 60601, 62304, 62366).

Responsibilities

• Lead surgical navigation and computer vision product development program.
• Manage multi-disciplinary product development team (electrical, mechanical, software, algorithms, systems).
• Develop and maintain technology strategy and roadmap.
• Coordinate regulatory submissions and quality/compliance activities.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory compliance

Design controls

Education

Bachelor’s degree (10+ years related experience)

Master’s degree (7+ years)

Tools

Microsoft Project

Windows

Job description

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: 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. Primary 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. Qualifications: 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. Physical Demands: The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Required to sit; climb or balance; and stoop, kneel, crouch or crawl Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus Our Values: Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven. Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions. Customer Focused: We listen to our customers’ needs and respond with a sense of urgency. Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger. Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. Equal Employment Opportunity: Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 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.