MDR - Packaging Engineer at Artech Information Systems LLC
Boulder, CO
About the Job
| 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 | |||
| Description | |||||
| Job Title: MDR - Packaging Engineer Location: 6135 Gunbarrel Ave, Boulder, CO 80301 Duration: 12 Months Description: 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: 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 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. Vishnu T Team Lead - Staffing 360 Mt. Kemble Avenue, Suite 2000 Morristown, NJ 07960 Office: 973.967.3510 |Cell: 651-634-1454 Email:vishnu.t@artech.com Website:www.artech.com | |||||
Benefits
- Life Insurance
- Flexible Spending Accounts
- Employee Referral Program
- Long Term Disability
- Employee Events
- Medical, Dental and Vision
- 401K