IntePros
Overview
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
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.
Lead successful validation of packaging systems for medical devices.
Identify and develop innovative packaging processes and designs as part of a cross functional team. Determine 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 with 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 / Qualifications
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.
Education
Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
Senior/Employment Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
Industries: IT Services and IT Consulting
Software knowledge is preferred. CAD/CAPE/TOPS
Additional notes: The role is onsite 4 days a week, with W2 only; no C2C. Onsite location considerations include Denver/Boulder, CO area with multiple postings in related CO locations.
#J-18808-Ljbffr
Responsibilities
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.
Lead successful validation of packaging systems for medical devices.
Identify and develop innovative packaging processes and designs as part of a cross functional team. Determine 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 with 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 / Qualifications
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.
Education
Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
Senior/Employment Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
Industries: IT Services and IT Consulting
Software knowledge is preferred. CAD/CAPE/TOPS
Additional notes: The role is onsite 4 days a week, with W2 only; no C2C. Onsite location considerations include Denver/Boulder, CO area with multiple postings in related CO locations.
#J-18808-Ljbffr