The Planet Group
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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40-50/h pay
Top skills needed:
a. 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
b. 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
c. Lead project meetings and provide updates to management
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 Tech File remediation and collaborates with stakeholders to achieve desired results. Responsibilities include the following:
Minimum Requirements
MDR - Packaging Engineer
6135 Gunbarrel Ave Boulder, CO 80301 US
Posted: 09/09/2022
2022-09-09
2022-10-29
Employment Type:
Contract
Job Category: Engineering
Job Number: 506767-1
Country: United States
Is job remote?: No
Job Description
40-50/h pay
Top skills needed:
a. 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
b. 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
c. Lead project meetings and provide updates to management
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 Tech File remediation 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.
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