Packaging Engineer (Medical Device packaging)

Position Title

Principal Accountabilities

Special Skills

Accountability

Manager update :

• Packaging design development for medical devices or Pharma industry
• Packaging verification and validation for medical devices or Pharma industry
• Design control process for medical devices
• CAD tools for packaging design
• Packaging standards and regulatory requirements for medical devices (i.e. ISO11607, EUMDR, etc.)

Qualification

• 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

Experience

• 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
• 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

Accountability

• Will not manage any direct reports
• Will not be responsible for any functional areas
• Knowledgeable and adherent to BD Quality and Corporate Policies