Engineering Specialist (Validation)

Support the evaluation, qualification, and documentation of computerized systems and manufacturing processes. This role is ideal for a detail-oriented professional with experience in FDA-regulated environments and strong bilingual communication skills.

Responsibilities may include the following and other duties may be assigned:

• Evaluate the impact of validated computerized systems on existing work instructions and processes.
  

• Prepare and execute computer system validation protocols and generate comprehensive reports.
  

• Develop and maintain Installation Qualification (IQ) documentation.
  

• Collaborate with process owners to implement changes to work instructions and ensure compliance.
  

• Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
  

• Ensure adherence to company procedures, quality system regulations, and industry standards.
  

• Apply technical expertise and knowledge of Medtronic’s engineering practices to optimize equipment and manufacturing techniques.
  

• Organize and track project progress, maintaining detailed documentation and status updates.
  

• Contribute to cross-functional projects and support milestone completion.
  

• Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.
  

Requirements

• Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
  
  
• Practical knowledge and demonstrated competence in validation and quality systems
  
  
• Bachelor’s degree in Engineering.
  

Top 3 Qualifications: 

• Hands-on experience in Process and Computerized Systems Validation
  

• Background in FDA-regulated industries (e.g., medical devices, pharmaceuticals, biotech)
  

• Excellent verbal and written communication skills in both English and Spanish