8+ years' experience in medical device product development and research; 5+ years in management
Bachelor's Degree in Engineering or a technical field; Master's Degree preferred
Experience in new product introduction and lifecycle management
Strong project management capabilities
Proven complex problem-solving skills
Excellent oral and written communication abilities
Willingness to travel up to 15-20% of the time
Responsibilities
Lead the Spine team to innovate new products like implants and instrumentation
Conduct thorough market analyses for product segments to identify new opportunities
Ensure compliance with Quality activities like CAPA and MDR for products
Develop and validate pre-clinical and clinical data for new technologies
Support educational initiatives including courses and labs, ensuring equipment compliance
Create and produce marketing materials such as technique guides and brochures
Work with Regulatory Affairs on submissions like 510(k) and IDE
Benefits
Commitment to a diverse and inclusive workforce
Opportunities for professional growth and career advancement
Culture that prioritizes patient care and innovation
Supportive team environment that values collaboration and respect
Focus on compliance with industry standards and ethical practices
Full Job Description
The responsibilities of the position include, but are not limited to, the following:
Successfully leading the Spine team to develop new products (i.e. implants & instrumentation)
Performing and maintaining market analysis by each product segment to identify new product offerings and line extensions to ensure Globus has the best product offering in industry for this group
Overseeing all Quality Compliance activities for products within department including complaint, CAPA, MDR, NCMR, and all relevant compliance activities
Developing sound mechanical, pre-clinical, and clinical data of scientific merit on all technologies developed
Providing support for all educational activities including MERC courses, symposia, think tanks, delta force meetings, cadaver labs, and in-house courses. Responsible to ensuring that all Globus equipment at these meetings are up-to-date and only promoted by Globus in accordance with its approved labelling
Creating marketing literature, including all technique guides, brochures and other marketing/sales support materials
Partnering with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE & PMA submissions and approvals
Collaborating with VP, Strategy & Corporate Development to ensure that Globus can attract and retain the best orthopedic/trauma surgeons to serve on product development teams, surgeon boards, think tanks, podium speakers, etc.
Creating marketing literature, including all technique guides, brochures and other marketing/sales support materials
Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
Representing the company in a professional manner and upholding the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
In order to be qualified for this role, you must possess the following:
8+ years' experience in the medical device product development and research field; 5+ years of people and or program management experience
Bachelor's Degree in Engineering, Business, or a technical field; Master's Degree preferred
Ability to work under minimum supervision with a high degree of organizational, technical, and business competence Experience in new product introduction, design control process and lifecycle management
Strong project management skills
Proven ability to resolve complex issues, solve problems, and resolve customer related issues
Excellent oral and written communication skills
Ability to travel up to 15-20% of the time
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.
About Globus Medical
Globus Medical is a medical device company that develops and manufactures products for patients with musculoskeletal disorders. The company's products include spinal implants, surgical instruments, and orthopedic implants. Globus Medical was founded in 2003 and is headquartered in Audubon, Pennsylvania. The company has a strong focus on research and development and has received numerous awards for its innovative products. Globus Medical is committed to improving patient outcomes and has a strong reputation for providing high-quality products and services.