Group Engineering Manager- Biomaterials Globus Medical
The Group Engineering Manager, Biomaterials will be responsible for managing product development in the core areas of resorbable devices, bone graft materials, growth factors, disc repair devices. The person needs to have leadership qualities to hire and lead a dynamic group of Product Engineers and Product Managers. The position will be a hands-on with the individual capable of creative and systematic product development under the supervision of the Director. 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.
Successfully lead the group in the developing a variety of Biomaterials related products.
Responsible for recruitment, hiring, and training of employees to fill positions as they arise to create a strong group including engineers and product managers.
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 for this group.
Responsible for developing device in compliance with FDA Design Control/ISO Product Realization requirements.
Responsible for all Quality Compliance activities for products within department including complaint, CAPA, MDR, NCMR, and all relevant compliance activities
Development of sound mechanical, pre-clinical, and clinical data of scientific merit on all technologies developed
Provide 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
Work closely with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE & PMA submissions and approvals
Work closely with VP, Strategy & Corporate Development to ensure that Globus can attract and retain the best spine surgeons to serve on product development teams, surgeon boards, think tanks, podium speakers, etc.
Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical Investigator Groups, surgeons, and sales force
Create marketing literature, including all technique guides, brochures and other marketing/sales support materials
Special projects and duties as assigned
>5 years experience in product development and/or research
Must have experience with polymer, ceramic, and composite product development
Must have working knowledge of design control
Must have experience managing a product development team
Bachelor?s Degree in Engineering or Business, Master?s Degree recommended
Working knowledge of Windows, Microsoft Office, E-mail, and Microsoft Project
Excellent oral and written communication skills
Ability to travel up to 15-20% of the time
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin.
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2560 General Armistead Avenue
Audubon, PA 19403