Xtant Medical

Process Engineer

Title: Process Engineer
Status: Full-Time, Exempt
Location: Belgrade, MT

Summary:

Why Xtant Medical?

JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.

Position Summary

Xtant Medical is seeking talented and dedicated Process Engineer that will support the company mission to market regenerative medicine products and medical devices.  The primary responsibility of the Process Engineer will be to initiate, develop, and help implement process-related projects to achieve regulatory compliance, lower costs, improve quality, improve existing processes, assist in evaluating new technologies, implement engineering changes, and evaluate and establish new processes. This includes studying existing and new processes to help identify and implement improvements. This position will work within the Research and Development Department, and cross-functionally with several other departments as each project requires.

Principle Duties & Responsibilities

  • Initiate, develop, and help implement process-related projects to achieve regulatory compliance, lower costs, improve quality, improve existing processes, assist in evaluating new technologies, implement engineering changes, and evaluate and establish new processes.
  • 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 practices.
  • Adhere to Xtant Medical 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 Xtant Medical products and general biological and chemical systems utilized within the Company. Understand how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production and quality of medical devices and tissues.
  • Review existing processes for improvements in efficiency, process productivity, and cost. Evaluate process improvement projects for feasibility and compliance with current validations, common practices and regulations. Evaluate the extent of revalidation needed for process changes.
  • Propose and execute process improvement projects. Transfer technology including process improvements into production. Train Processors, Engineering, and R&D staff as needed.
  • Design experiments and interpret experimental data generating informed analytical decisions for process improvement.
  • Develop and manage multiple projects with a focus on achieving cost and timeline objectives with measurable results.
  • Work with Facilities Engineering to test new production equipment, help to perform validations, and develop the appropriate documentation.
  • Contribute to problem solving for technical issues and/or complaints for existing products.
  • Work on process improvements and line extensions, making SOP changes as necessary.
  • Work with the design and development teams as assigned on new products, implementing design for manufacturability. May assist in Design Control activities.
  • Write and/or revise SOP’s, Work Instructions, Forms, Protocols, Reports, and other documentation. Train staff on changes to documents.
  • Own, maintain, and report to Department Director on financial impact of prospective, in-progress, and completed projects.
  • Prepare presentations describing proposed solutions and advise Department Head of status of projects and tasks.
  • Work to investigate and process CAPA’s and Non-Conformances in a timely manner as assigned.

Position Requirements

  • Knowledge of current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR)
  • Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma or DMAIC).
  • Requires the ability to apply scientific and analytical principles for proper design of experiments and validations and provide sound interpretation of results.
  • Proven ability to perform effective literature searches
  • Extensive knowledge of FDA and ISO regulations and standards required; knowledge of AATB standards preferred
  • Experience with Process Mapping desired
  • Applied knowledge of project management methodologies preferred
  • Experience in Medical Devices and/or Tissue Banking required
  • Proven ability to write, review, and edit technical documents
  • Working knowledge of CAD/CAM desired
  • Advanced ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups.
  • Must possess excellent organizational skills and strong attention to detail
  • A demonstrated ability to perform in cross-functional teams to achieve objectives within required time frames.
  • Must demonstrate a high level of ethical behavior and possess a work ethic that includes neatness, punctuality, and accuracy

Education/Knowledge/Skills Required

  • Bachelor’s degree or higher in an Engineering or Science field is required. Knowledge of chemistry, microbiology, and biochemistry preferred.
  • 2-3 years’ process engineering experience in a GMP regulated environment required, 5 years’ experience preferred.
  • Six Sigma Green Belt required; Black Belt preferred.
  • Must have or be willing to acquire Certified Tissue Bank Specialist (CTBS) certification.

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.