Packaging Engineer (Medical Device packaging)

About the role

This position is located in Franklin Lakes, New Jersey. This is an on-site role.

Qualifications and experience

• Education: Bachelor Degree equivalent in Packaging, Mechanical Engineering, Materials Engineering or in a related field of study.
• Experience: Minimum 2 years of experience in Medical Device packaging.
• CAD: Being able to modify, generate drawings in SolidWorks.
• Lab equipment knowledge: Being able to use sealing equipment, dispensing equipment, basic tools.
• Experience in test method validations.
• Experience in root cause analysis methodologies.
• Experience in statistical tools using Minitab to design DOE's, data analysis such normality, tolerance intervals, regressions.
• Experience with prototyping and being able to use equipment like a flow wrapper.
• Experience in Med devices in design verification.
• Documentation: Proficient in writing protocols and reports.
• 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.
• Knowledge of the following standards: ISO 11607, ISO 13485, ISO 14971.

Principal accountabilities

• Demonstrates working knowledge of package engineering principles and techniques.
• Demonstrates working knowledge of legal requirements and documents.
• Designs, prototypes and qualifies standard new packaging concepts in accordance with design control requirements with moderate guidance.
• Evaluates and improves standard existing packaging concepts with moderate guidance.
• Identifies, analyzes and specifies standard packaging materials and equipment with moderate guidance.
• Supports external resource/contractors as required.
• Has developed knowledge and skills in packaging; still acquiring / expanding fundamental knowledge and higher-level skills.
• Applies knowledge and skills to a variety of standard activities.
• Works with moderate guidance in own area of knowledge.

Special skills

• 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.