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.
Xtant Medical is seeking a talented and dedicated R&D Engineer II that will support the company mission to market regenerative medicine products and medical devices. The R&D Engineer will help initiate, develop, and implement product development projects to generate new product platforms, products and line extensions.
These objectives will encompass the following activities: assist in evaluating new processes, assist in identifying, developing, and validating test methods, design for manufacturability, project management, design control, risk identification and mitigation, maintain a high level of regulatory and product knowledge, help maintain regulatory compliance, and help ensure department activities conform with company QMS. This position will work within the Research and Development Department, and cross-functionally with other departments as each project or task requires.
Principle Duties & Responsibilities
- As part of a team, initiate, develop, and implement product development projects to generate new product platforms, products and line extensions.
- 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 processes. Understand how the activities performed in the Department interact with the Quality System and how they affect the production and quality of Xtant products.
- Perform literature and patent searches to support R&D activities. Generate new intellectual property.
- Perform risk assessments and develop FMEAs.
- Design and execute complex lab and outsourced animal studies as needed.
- Manage product development projects to meet design, budget, and timeline goals.
- Perform design verification and validation and test design and validation for product development projects. Execute design transfer activities and assemble DHFs.
- Perform process validation activities in preparation for manufacturing.
- Perform cell culturing and cell cryopreservation.
- Work with Facilities Engineering to test new production equipment, help to perform validations, and develop the appropriate documentation.
- Aid in process development.
- Perform sterilization validation, shelf life testing, packaging validations, and supplier evaluations.
- Contribute to problem solving for technical issues and/or complaints for existing products.
- Aid in evaluation of new technologies.
- 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 and schedule impact of prospective, in-progress, and completed projects.
- Prepare presentations describing proposed solutions and advise Department Head of status of projects.
- Work to investigate and process CAPA’s and Non-Conformances in a timely manner as assigned.
- Knowledge of current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR).
- Excellent general lab skills.
- Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma or DMAIC).
- Ability to design, plan and execute complex lab and animal studies, and provide sound interpretation of results.
- Ability to perform effective literature searches and generate summaries.
- Experience with Design for Manufacturing preferred.
- Ability to design and validate test methods.
- Advanced understanding of design controls; ability to plan and execute Design V&V and Design Transfer for several different device types.
- Thorough understanding of sterilization validation.
- Thorough understanding of process validation.
- Extensive knowledge of FDA and ISO regulations and standards required; knowledge of AATB standards preferred.
- Applied knowledge of project management methodologies preferred; ability to effectively manage projects according to timeline and budget constraints.
- Ability to write, review, and edit technical documents.
- Advanced ability to communicate effectively both orally and in writing and the ability to present effectively to small 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 strong work ethic that includes neatness, punctuality, and accuracy.
- Bachelor’s degree or higher in an Engineering or Science field is required. Master’s degree or higher is preferred. Knowledge of materials science, biomedical engineering, chemistry, microbiology, and biochemistry preferred.
- 3 years’ experience in a GxP regulated environment required, 6 years’ experience preferred.
- 3 years’ experience developing and maintaining aseptic processes required, 5 years’ experience preferred. Experience with stem cells required.
- Experience in Medical Devices and/or Tissue Banking required
- 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.
No H1B Sponsorships Available for this Position
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.