Job Description

Job Tittle: Engineer I - Shift 1

Location: Southington, CT

Duration: 12+ months contract

Pay rate: $33.00/ Hr on W2.

Shift Timing: 1st Shift

Job Description:

Qualifications:

• Bachelor’s degree in Science or Engineering from an accredited college or university.
• Working knowledge of Documentation Change Management Process in a Medical Environment.
• Agile Document Repository and Change Management process.
• Microsoft Project.
• Ability to read technical specifications, drawings, and understand labeling standards.
• Knowledge of plant quality requirements as to on market product.
• Communication skills with internal and external suppliers and management.
• Ease of interpersonal relationships, communication skills and methodical problem solving.
• Minimum of 3 years in the manufacture of medical devices industry or combination of medical device or pharmaceutical industry.

Responsibilities:

• Writing and executing several Design Development Plans and project plan schedules for each product family to be changed.
• Overseeing Artwork Change and verification that it is correct for each List Number involved in the name change.
• Redling Artwork and Packaging Component Specifications for revised changes.
• Progressing these changes through our Agile Change Management structure.
• Working with the Supplier Change Notification process and Supplier Quality in any artwork name changes associated with purchased finished components.
• Working with R&D, Quality, Regulatory, Design Assessors and Plant Engineering to implement these name changes for all levels of packaging into production.
• Preparing and executing Change Management documentation to include Purchasing Specs, Artwork drawings and updating Bill of Materials.
• Ensuring smooth transition in artwork changes as needed to ensure continuity of documentation specs, IFU materials, and packaging materials.
• Communication with management to provide updates on project status and or contingency plans to ensure continuity of supply of materials used for on-market product and third party contracted product.
• Coordinate within groups to prepare and execute DDP (Design Development Pan) and any associated Validations for this Medical Packaging name change.
• Coordinating with additional site PM working on the same project to ensure consistency of implementation across sites.
• Prepares presentations, graphs, plans, forms, reports, etc. or any other document that is required to communicate project progress to management.
• Follows the standard operating procedures, rules and regulations established by entities related to the manufacture of medical products.
• Other responsibilities typical of the position as assigned by Project Management for this project.

Job Tags

Similar Jobs