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MDR - Packaging Engineer

Integrated Resources, Inc Boulder, CO

  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Title: MDR - Packaging Engineer
Duration: 12 months
Location: Boulder, CO

Description:

Candidate must be local to Boulder, CO.

The Packaging compliance engineer is part of a dynamic team that provides expertise in the areas of packaging engineering and ensures quality and regulatory compliance. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Responsibilities may include the following and other duties may be assigned:
  • Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
  • Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
  • Leads successful validation of packaging systems for medical devices
  • Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
  • Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
  • Lead project meetings and provide updates to management.
  • Assist in labeling development process.
  • May perform and evaluate testing in a laboratory environment as per industry standards.

Minimum Requirements
  • Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
  • Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
  • Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
  • Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.
  • Established and productive individual contributor with strong team and interpersonal skills.
  • Knowledge of Microsoft Office programs is required.
  • CAD/CAPE/TOPS Software knowledge is preferred.

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Integrated Resources, Inc

Address

Boulder, CO
80301 USA
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