To apply for this position, please visit our company Careers Page at https://xtantmedical.com/careers/
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 Process Engineer III that will support the company mission to market regenerative medicine products and medical devices. Primary responsibilities of the Engineer III will be to initiate, develop, and implement process and product related projects to improve efficiency, throughput, and cost in Biologics Operations, while ensuring regulatory and quality compliance. This position will also analyze existing and new processes to help identify and implement improvements.
The successful candidate will be a resource committed to building highly defined processes within our tissue processing operations, identifying and implementing necessary in-process measurements for process control and quality control, helping to build out our system requirements for an ERP and any changes to existing processes. The successful candidate will also have solid experience in volume manufacturing and understanding of medical device requirements.
Job Responsibilities and Duties:
- Develop and implement process improvement projects to achieve regulatory compliance.
- Utilize and interpret production data to characterize process performance and drive objective process/product decisions.
- Leverage Design Controls expertise to evaluate process improvement projects for feasibility and compliance with current validations, common practices and regulations.
- Train Tissue Processors and associated technicians, Engineering staff, and R&D staff as part of engineering changes.
- Conduct necessary process validations and/or product verification activities associated with process change implementation.
- Work with cross-functional teams to develop and implement process improvement projects to achieve regulatory compliance, lower costs, improve quality, and increase efficiency and throughput within Operations.
- Develop and manage multiple projects with a focus on achieving cost and timeline objectives with measurable results.
- Work with production teams to develop solutions to routine problems within Biologics Operations.
- Develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance, and other personnel.
- Execute problem solving for technical issues and/or complaints for existing products.
- Keep abreast of industry knowledge and manufacturing technology to ensure subject matter expertise for process and product related items.
- Develop highly defined processes within tissue processing operations, identify and implement necessary in-process measurements for process and quality control.
- Help build out system requirements for Enterprise Resource Planning (ERP), and any other changes to existing processes and line extensions, making SOP changes as necessary.
- 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 Senior Manager on financial impact of prospective, in-progress, and completed projects.
- Prepare presentations describing proposed solutions and advise Senior Manager of status of projects and tasks.
- Work to investigate and process CAPA’s and Non-Conformances in a timely manner as assigned.
- Work with Quality teams to ensure processes meet Quality and Regulatory requirements for CFR 1271, CFR 820, ISO 13485, and Good Manufacturing Practices (GMP).
- Design experiments and interpret experimental data generating informed analytical decisions for process improvement.
Educational Requirements and Experience Requirements:
- Bachelor’s degree or higher in an Engineering or Science field is required (Mechanical Engineering, Biomedical Engineering, etc).
- Preferred knowledge areas: biology/cell-biology/biochemistry, anatomy and physiology.
- 4-6 years’ process engineering experience in a volume manufacturing environment is required; 4-6 years of GxP environment preferred.
- Experience in Medical Devices and/or Tissue Banking and Design Controls methodology is required.
- Six Sigma Green Belt or Black Belt is strongly preferred.
- Applied knowledge of process improvement and project management methodologies is strongly preferred.
- Experience in Quality Engineering is preferred.
- Must have or be willing to acquire Certified Tissue Bank Specialist (CTBS) certification.
- Knowledge of current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR)
- Requires extensive use of Problem Solving and Process Improvement Methodologies (e.g. Six 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 is preferred.
- Experience with Process Mapping is desired.
- Applied knowledge of project management methodologies preferred.
- Proven ability to write, review, and edit technical documents.
- Working knowledge of CAD/CAM is required.
- 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.
** This position does not offer Visa Sponsorship **
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.