Validation Engineer

Job Title: Validation Engineer Location : Fort Worth, TX *Onsite Duration : Long Term X medtronic preferred JOB DESCRIPTION An individual contributor with responsibility in our technical functions to advance existing technology. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills.

• Responsibilities may include the following and other duties may be assigned.
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.
• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecycle ( from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with Minitab)
  
  

Other skills:

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices
• a Computer System Validation Engineer III
  
  

Top 3 technical skills that are required for the role:

• Project management
• Validation and qualification
• System integration and manufacturing process design
  
  

Education Required:

• Mechanical Engineering degree; open to other disciplines. As long as they have strong background in manufacturing in highly regulated field
  
  

Best Regards,

Trevor Claud

Recruitment Manager

BN Associates Inc.,

13873 Park Center Rd Suite # 187, Herndon VA 20171

"Certified SBA 8(a), EDWOSB, WOSB, WBE and MBE"

Our Certifications: ISO 9001 : 2015 Certified | ISO 27001 : 2022 Certified | ISO 20000 : 2018 Certified

Tel: 703-574-1549 | E-Mail: trevor.c@bnassociates.net