Demo

Project Engineer

Oxenham Group LLC
Saint Paul, MN Full Time
POSTED ON 12/11/2024
AVAILABLE BEFORE 2/10/2025
Job Summary

Our client seeks a Contract Engineer to support manufacturing operations and improve medical disposable products. This role involves IQ/OQ/PQ activities, risk management, process development, training, and LEAN implementation in medical product manufacturing.

Essential Duties & Responsibilities

  • Implement verification and validation activities.
  • Adhere to project schedules.
  • Facilitate project plans and risk analysis, implementing solutions.
  • Design manufacturing jigs, fixtures, and equipment.
  • Develop work instructions and internal label specifications.
  • Process document change orders (DCOs) accurately and promptly.
  • Support manufacturing to meet quality standards, cost targets, and schedules.
  • Develop safe, mistake-proof processes with clear instructions.
  • Assist purchasing with documentation and vendor qualification.
  • Perform failure analysis, corrective, and preventive actions.
  • Provide cost and expense information to accounting.
  • Additional duties as assigned.

Education & Experience Requirements

  • Bachelor's Degree in Manufacturing or Process Engineering OR equivalent experience.
  • Medical device industry experience.
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project, SolidWorks, and Minitab.
  • Knowledge of Lean Manufacturing, packaging, labeling, cleanroom, and sterilization processes.
  • Experience with semi-automated equipment implementation, including quotes, design inputs, and validations (FAT, SAT, IQ, OQ, PQ).
  • Knowledge of materials selection, biocompatibility (ISO 10993), and design for manufacturing.
  • Familiarity with FDA and ISO design control regulations.

Preferred Skills & Abilities

  • Strong communication and organizational skills.
  • Mechanical aptitude for equipment installation, repair, and maintenance.

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