Manufacturing Validation Specialist

5 days ago


New Haven, Connecticut, United States Syntricate Technologies Full time
Job Title: Manufacturing Validation Engineer

We are seeking a highly skilled Manufacturing Validation Engineer to join our team at Syntricate Technologies. As a key member of our organization, you will be responsible for ensuring the quality and reliability of our medical devices.

Key Responsibilities:
  • Develop and implement process and equipment qualification protocols (IQ/OQ/PQ)
  • Design and validate test methods for Design V&V, Process Validation, and Production
  • Validate test methods and execute engineering builds, gauge R&R studies, attribute analysis studies, and other validation work
  • Author and release new test methods and edit/redline existing ones
Requirements:
  • Bachelor of Science in Engineering or equivalent combination of education and experience
  • 5+ years of relevant experience in medical device manufacturing
  • Expertise in medical device manufacturing and strong working knowledge of cGMPs
  • Clean room environment experience and manufacturing engineering and automation experience
  • Experience with Test Method Validation and/or Measurement System Analysis is preferred
  • Knowledge of computer software for data analysis, specifically Microsoft Excel and statistical packages (Minitab preferred)
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485
  • Strong organizational skills, detail-oriented, and ability to collaborate across functional departments
  • Ability to work to deadlines and handle multiple tasks simultaneously
  • Experience with Microsoft Office, including Word, Excel, PowerPoint, and Project

We offer a dynamic and challenging work environment, opportunities for growth and development, and a competitive compensation package. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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