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Tissue and Biologics R&D Engineer

confidential

Belgrade, MT

Posted 3 months ago

Seeking an R&D Tissue and Biologics Engineer for a direct hire opportunity in Belgrade, MT. The engineer will initiate, develop, and implement process and product-related projects to improve efficiency, throughput, and cost while ensuring regulatory and quality compliance. Where applicable, this position will study existing and new processes to help identify and implement improvements. 

Duties and Responsibilities

  • Develop and maintain an understanding of the requirements of the applicable standards and regulations including, but not limited to, 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485. Adhere to and promote compliance with the applicable standards and regulations throughout the company 
    • Support Xtant Medical’s mission, values, and Quality Policy
    • Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
    • Develop and maintain an understanding of the Xtant Medical 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
    • Adhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocols
    • Complete annual SOP review and OSHA safety training as applicable
    • Provide input to 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
    • Assist in the design of experiments and interpret experimental data generating informed analytical decisions for process improvement
    • Develop and manage multiple projects, using project management skills with a focus on achieving cost and timeline objectives for capital expense projects 
    • Collects production data and applies standard scientific and statistical methods to analyze, document, and diagram the production process
    • Contribute to problem-solving for technical issues and/or complaints for existing products
    • Support existing product/process development by evaluating data from production, NC/complaints (with root cause investigation), and engineering studies
  • Maintain strict confidentiality of all company and customer information
    • Submit timely expense reports and abide by the Expense Reimbursement Policy
  • Participate in training plans and programs and complete in a timely manner within set deadlines
    • Complete required training before attempting to perform a task
    • Maintain required training documentation
  • Write, review, and revise a variety of technical documents including SOPs (Standard Operating Procedures), specifications, training documents, and processing protocols as needed
    • Legibly and accurately complete all documentation associated with assigned duties and review the information of others as required
    • Participate in changes to documents and to products and processes
    • Maintain information in physical and electronic files as required
  • Complete required training before performing tasks, including initial orientation and environmental health and safety training. Keep training up to date
    • Perform all duties according to established procedures and follow appropriate safety precautions and measures
    • Supports operating units by identifying and clarifying problems; evaluating potential solutions; implementing selected solution
    • Must maintain confidentiality of donor and recipient information according to HIPAA
Contact the Recruiter:
Kimberly Parks
Talent Advisor
Kimberly Parks
Talent Advisor
(847) 692-0621
(847) 692-0621
Kim recruited me for my current opportunity, and I could not be more impressed with her ability to identify such a strong fit for my background. I am settled into my new position and things are going great. I appreciate all her guidance throughout the process and would recommend her to anyone who is in the market for their next opportunity.
– Jose P | EHS Professional
Messina Group is an Equal Opportunity Employer
We provide and promote equal employment opportunities without regard to race, color, religion, age, sex, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression.
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Tissue and Biologics R&D Engineer

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