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Senior Manufacturing Engineer

INTELLECTT INC
North Haven, CT Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 6/3/2025

Manufacturing Engineer North Haven, CT (Onsite)

Experience : Minimum 610 years in medical devices

Duration : 12 years (Contract)

Key Responsibilities :

  • Support manufacturing processes, quality engineering, and process validation.
  • Conduct Time Studies and improve assembly line efficiency.
  • Troubleshoot safety, quality, and production issues.
  • Perform IQ, OQ, PQ validations and develop process improvements.
  • Design and implement tooling, fixtures, and automation solutions .
  • Collaborate on risk analysis, CAPA, and compliance initiatives .
  • Work with cross-functional teams to enhance production performance.
  • Ensure ISO 13485 and 21 CFR Part 820 compliance.
  • Utilize Minitab, DOE, Six Sigma, and SPC for process control.

Requirements :

  • BS / MS in Mechanical Engineering, Packaging Science, or related field .
  • Medical device manufacturing experience with Class 2 & 3 devices.
  • Expertise in automation, robotics, vision systems, and inspection tools .
  • Strong background in NPI, process optimization, and statistical analy sis
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