Packaging Engineer

Millenniumsoft • Franklin Lakes, NJ

6d • Hybrid

About The Position

The role is on site up to 5 days a week, also depending on COVID. There will be also days when work can be done remotely from home using the Client laptop. The Packaging Engineer will work with suppliers and identify, analyze, and specify packaging materials and equipment with moderate guidance. They will design, prototype, and qualify new packaging concepts in accordance with design control requirements with moderate guidance. The role requires a working knowledge of package engineering principles and techniques, and the ability to evaluate and improve existing packaging concepts with moderate guidance. The engineer will develop and manage execution for feasibility engineering studies, including protocols and reports, as well as Design Verification studies, including DV Plans, Protocols and Reports. They will demonstrate working knowledge of regulatory and legal requirements and documents related to packaging for medical devices and work with moderate guidance in their area of knowledge. This role will not manage any direct reports or be responsible for any functional areas. The individual must be knowledgeable and adhere to BD Quality and Corporate Policies.

Requirements

• Packaging design (including materials) development for medical devices or pharma industry: primary, secondary and tertiary packaging
• Packaging verification and validation for medical devices or pharma industry
• Design/change control process for medical devices
• Packaging standards and regulatory requirements for medical devices (i.e. ISO11607, EUMDR, etc.)
• Experience working in a cross-functional team.
• Bachelor Degree equivalent in Packaging, Mechanical Engineering, Materials Engineering or in a related field of study.
• minimum 2 years of experience in Medical Device packaging
• Demonstrates working knowledge of package engineering principles and techniques
• Demonstrates working knowledge of regulatory and legal requirements and documents related to packaging for medical devices.
• Effectively communicates technical knowledge and validates understanding of other packaging test methods/standards and related equipment.
• Medical device packaging system development for flexible and rigid packaging applications.
• Packaging system verification and validation experience
• Experience/knowledge with CAD tools for packaging design
• Experience with statistics and design of experiments.
• Knowledge of the following standards: ISO 11607, ISO 13485, ISO 14971

Responsibilities

• Works with suppliers and identifies, analyzes, and specifies packaging materials and equipment with moderate guidance.
• Designs, prototypes and qualifies new packaging concepts in accordance with design control requirements with moderate guidance.
• Evaluates and improves existing packaging concepts with moderate guidance.
• Develop and manages execution for feasibility engineering studies including protocols and reports.
• Develop and manages execution for Design Verification studies including DV Plans, Protocols and Reports.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level