Xtant Medical

Hardware Product Manager

Title: Hardware Product Manager
Status: Full-Time, Exempt
Location: Remote - U.S.

Summary:

To apply for this position, please visit our company Careers Page at https: //xtantmedical.com/careers/

Why Xtant Medical?

JOIN A RISING organization that unites exceptional biologics with intuitive fixation design to inspire surgical solutions that advance regenerative medicine.  Our vision is to be the leader in regenerative medicine by continuously elevating the standard of care. Xtant Medical’s mission is to develop, acquire, manufacture, and commercialize innovative, quality regenerative surgical products for the treatment of degenerative, traumatic, and deformity conditions for orthopedic and neurological applications.

Position Summary

This position is responsible for overseeing all assigned Xtant products and working directly with Sales, Marketing, Operations, and R&D departments to promote Xtant products, aide in the development of new products, provide technical assistance to the sales force and distributors, and gather information on the design, performance, and utilization of Xtant products. This position will act as a liaison between many departments within the company.

Essential Duties & Responsibilities

  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice.
  • Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards.
  • Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable.
  • Support Xtant’s mission to develop, acquire, manufacture, and commercialize innovative, quality regenerative surgical products for the treatment of degenerative, traumatic, and deformity conditions for orthopedic and neurological applications.
  • Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures.
  • Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees.
  • Manage day-to-day progress of assigned product lines.
  • Responsible for developing marketing materials along with the Marketing Department for new product launches or updates to existing or old literature, advertising ideas, direction, conference support, etc.
  • Produce competitive analysis and materials comparing product with its key competitors.
  • Aiding in the creation and maintenance of training and in-service materials for product line and conduct product trainings and seminars to internal and external personnel as requested.
  • Effectively communicate updates on products, the market, and competitive activities with Sales, Customer Service, National Accounts, R&D.
  • Provide technical support to the sales force and travel to assist in meeting sales objectives as needed.
  • Work with senior marketing members to conduct on-going research to define market needs (includes interfacing with hospital personnel, surgeons, nurses, and sales representatives, surgical observation, and literature review) to develop and maintain product lines.
  • Support the development and launch of new products and gather post-market feedback by serving as the interface between surgeons, end users, R&D, and QA/QC.
  • Serve as a point of communication between R&D, Marketing, Sales, and Operations to make sure new products are effectively introduced to the market in a coordinated fashion.
  • Work with senior marketing members, Operations, Accounting, and Sales to most effectively manage inventory based on current and projected sales volumes as needed.

Qualifications

  • Bachelor’s degree required, Masters or MBA preferred
  • 1-3 years of spinal hardware product knowledge is required
  • General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge preferred.
  • High level of proficiency in Microsoft Office Suite of software applications.
  • Ability to react quickly and adapt to changes in priorities, circumstances and direction.
  • Must be able to reason independently and work with minimum supervision.

Travel Required

  • 25-50%

Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages

Xtant Medical is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.