Packaging Engineer Medical Device

Job Title: Packaging Engineer Medical Device

Job Location: Lafayette, Colorado (Fully Onsite)

Type: W2 contract

Duration: 12 months

Job Description:

Technical skills that are required for the role:

1. Knowledge and working experience in Medical Device Package Design and qualification
2. Understanding of Packaging Engineering Industry Standards and regulations (i.e. ISO 11607-1,-2)
3. Experience in regulated industry, medical devices or pharmaceutical

Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.

Years Experience Required: Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering

The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads EU MDR packaging remediation projects and collaborates with stakeholders to achieve desired results.

Responsibilities include the following:

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 EU MDR 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 1-3 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.

Established and productive individual contributor with strong team and interpersonal skills.

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 preferred.

Knowledge of Microsoft Office programs is required.

CAD/CAPE/TOPS Software knowledge is preferred.