Validation Engineer Support

Hybrid in North Haven, CT, US • Posted 6 hours ago • Updated 6 hours ago
Full Time
Hybrid
$50 - $55/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • OQ
  • PPAP
  • PQ
  • Mechanical Engineering
  • Manufacturing Engineering
  • IQ
  • Design Of Experiments
  • Electrical Engineering
  • ROOT
  • Process Control
  • Mechatronics
  • Robotics
  • System Requirements
  • Management
  • Assembly
  • Machine Vision
  • Statistics
  • Motion Control
  • Manufacturing
  • Inspection

Summary

Candidate should have prior Medtronic experience (mandatory).
Key Responsibilities:
  • Oversee and optimize complex production processes for surgical devices, ensuring alignment with efficiency and quality standards.
  • Act as the primary technical expert for electro-mechanical equipment issues, identifying root causes and implementing sustainable corrective actions to minimize downtime.
  • Lead the development and execution of validation strategies, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for new and existing equipment.
  • Apply Lean principles to identify opportunities for waste reduction and process stability.
  • Lead non-conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations to uphold strict quality system requirements.
  • Support the adaptation of machine or equipment design to factory and production conditions

Qualifications Required:
  • Bachelor s degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
  • 10+ years of relevant manufacturing engineering experience (or 8+ years with a Master s degree).
  • Mastery of medical device process validation (IQ/OQ/PQ), statistical analysis (Minitab), and high-volume manufacturing assembly.
  • Proven ability to troubleshoot complex automated systems including robotics, motion control, and machine vision.
  • Strong background in statistical analysis, including process capability, process control, DOE, and inspection design
  • In-depth understanding of Production Part Approval Process (PPAP) for component qualification
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91132048
  • Position Id: 8914490
  • Posted 6 hours ago
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