Packaging Engineer

7 days ago


Lafayette, Colorado, United States ValidIT solutions LLC Full time

Position: Packaging Engineer – Medical Devices

Overview:

Seeking a Packaging Engineer to design and develop sterile and non-sterile packaging for spinal implants and instruments. The role involves managing OEM packaging projects, maintaining Design History Files, and ensuring compliance with FDA and ISO standards.

Key Responsibilities:

  • Design, develop, and test medical device packaging for protection, handling, and compliance.
  • Create and manage documentation per GMP and QMS requirements.
  • Lead cross-functional teams to drive project execution on time and within scope.
  • Apply scientific problem-solving (DMAIC, risk management) and process validation methods.
  • Utilize CAD tools (CREO/SolidWorks) and statistical software (Minitab).

Must Have:

  • 2–7 years in medical device design, development, and manufacturing.
  • Experience in sterile packaging (ethylene oxide, radiation, etc.).
  • Strong project management, problem-solving, and communication skills.
  • Knowledge of FDA/ISO standards and risk management.

Nice to Have:

  • Change control, equipment qualification, and process validation experience.
  • Six Sigma or DFSS certification.

Top Skills: CREO, Sterile Packaging Development, Project Management

Job Type: Contract

Pay: $ $40.00 per hour

Benefits:

  • Health insurance

Work Location: In person


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