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R&D Scientist I

confidential

Belgrade, MT

Posted 1 month ago

We seek an R&D Scientist for our client in Belgrade, MT to help initiate, develop, and implement both research and product development projects to generate new product platforms, products, and line extensions. These objectives will encompass the following activities: assist in evaluating new technologies and 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. 

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
    • As part of a team, initiate, develop, and implement both research and product development projects to generate new product platforms, products, and line extensions
    • 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 R&D projects to meet design, budget, and timeline goals as needed
    • Perform design verification and validation and test design and validation for R&D 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

Training

  • Participate in training plans and programs and complete in a timely manner within set deadlines
    • Complete required training prior to attempting to perform a task
    • Upon request, assist in the training of technical staff
    • Maintain required training documentation

Document Control and Record Control

  • 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 in accordance with GDP and review the written documentation of others as required
    • Assist in the completion and retention of documentation pertaining to all SOPs as required
    • Maintain information in physical and electronic files as required
    • Train on and demonstrate proficiency in Xtant Medical’s document control system

Performance of Duties

  • Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks. Keep training up to date
    • Perform all duties according to established procedures and follow appropriate safety precautions and measures
    • Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
    • Must maintain confidentiality of donor and recipient information according to HIPAA
    • Supports operating units by identifying and clarifying problems; evaluating potential solutions; implementing selected solution
Contact the Recruiter:
Kimberly Parks
Talent Advisor
Kimberly Parks
Talent Advisor
kparks@messinagroupinc.com
(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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R&D Scientist I