Packaging Engineer

The role entails self-management of Packaging Development activities including design and quality deliverables involving: Strategy, Requirements flow down, Reviews, Roadmap Alignment, Design Inputs, Design Outputs, Design Characterization, Usability, Risk management, Manufacturing support, Design Validation, Labeling, Change Management, and Support Issues.

· Designs, develops, and creates test protocols/reports for a wide variety of containers used for the protection, display, and handling of products.

· Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.

· Designs package exteriors considering such factors as product identification, Operating Room Workflow, aesthetic quality, printing and production techniques.

· Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Top 3 technical skills that are required for the role:

1. Medical Device Packaging Design (Sterile Packaging / Steam Sterilization Cases)

2. Project Management skills, including timeline management and design history file ownership (Excellent documentation/reporting skills/file organization)

3. CREO drawing software – Fully capable and comfortable with CREO

Education Required:

Bachelor of Science in Packaging, or Mechanical Engineering, or Biomedical Engineering

Years’ Experience Required:

Internship (2 to 7 years of experience preferred)

-Responsible for ensuring EU MDR Guidelines are met, and suggest where remediation steps may be needed.

-Update existing files to meet state of the art file expectations.

TECHNICAL SKILLS

Must Have

1. Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.

2. Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes). These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices

4. Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) 5. Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards. 6. Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools. 7. Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.). 8. Experience with Minitab or other statistical software.

Nice To Have

Experience developing Medical Device Case and Trays used with Steam Sterilization