Engineer II, Packaging

Contract Term: 6+ Months, 40 hours per week. This position starts as a 6-month contract with the possibility of extension for successful candidates.

About the Role

Medical Device Packaging Engineer with knowledge and experience in the regulated packaging industry. Minimum 2 years’ experience required.

Responsibilities

• Demonstrate working knowledge of package engineering principles and techniques.
• Demonstrate working knowledge of legal requirements and documents.
• Design, prototype, and qualify standard new packaging concepts in accordance with cGMPs with moderate guidance.
• Evaluate and improve standard existing packaging concepts with moderate guidance.
• Identify, analyze, and specify standard packaging materials and equipment with moderate guidance.
• Support external resources/contractors as required.
• Collect basic information needed to analyze a problem, situation, or issue.
• Perform routine or basic analysis, following correct steps and using appropriate tools, with guidance from senior staff.
• Identify basic implications/conclusions from logical analysis of routine situations or issues.
• Demonstrate understanding of functional goals and apply technical knowledge to develop basic solutions.
• Serve as a resource to others by answering basic questions pertaining to a specific area of expertise.
• Effectively communicate technical knowledge and validate understanding of others.
• Develop and apply packaging test methods/standards and related equipment.
• Develop medical device packaging systems for flexible and rigid packaging applications.
• Perform packaging system verification and validation.
• Apply knowledge of statistics and design of experiments.

Requirements

• Minimum 2 years of experience in packaging engineering, preferably in a regulated industry (e.g., medical devices).
• Experience with packaging system verification and validation.
• Knowledge of ISO 13485, ISO 11607, and ISO 14971 standards.
• Working knowledge of cGMPs (current Good Manufacturing Practices).
• Experience with statistics and design of experiments.

Skills

• Developed knowledge and skills in packaging, with the ability to expand fundamental and higher-level skills.
• Ability to work with moderate guidance in your area of expertise.
• Strong communication skills for conveying technical knowledge.