|Reference # :||20-37479||Title :||MDR - Packaging Engineer|
|Location :||Boulder, CO|
|Position Type :||Contract|
|Experience Level :||Start Date / End Date :||11/30/2020 / 11/29/2021|
|Job Title: MDR - Packaging Engineer|
Location: 6135 Gunbarrel Ave, Boulder, CO 80301
Duration: 12 Months
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.
• 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.
Team Lead - Staffing
360 Mt. Kemble Avenue, Suite 2000 Morristown, NJ 07960
Office: 973.967.3510 |Cell: 651-634-1454
- Life Insurance
- Flexible Spending Accounts
- Employee Referral Program
- Long Term Disability
- Employee Events
- Medical, Dental and Vision