Job Description

Must haves:

• Solidworks
• Minitab
• Medical device experience
• Packaging Design and Development
• Packaging design verification

Nice to have skills:

• Process Validation: IQ, OQ PQ experience.

Summary:

• Develop world-class capabilities and provide a competitive advantage to Edwards, through packaging design and project management.

Key Responsibilities:

• Design innovative packaging concepts for moderately complex projects, including new product launches and existing products throughout all stages of product development from concept to launch, including clinical trials, global and limited market releases, as well as key operations initiatives
• Develop protocols for, and implement, package design, packaging process validation, and package shelf life testing, as well as driving new packaging technologies and strategies with increased uncertainty and complexity, to improve time to market and advance the technology of package engineering at Edwards
• Develop plans for moderately complex projects working closely with cross-functional team members and outside suppliers
• Validate packaging equipment and packaging manufacturing processes to determine appropriate sourcing, purchasing, installation planning and specifications
• Provide guidance and coaching to lower level engineers

Education/Experience:

• • Bachelor's degree in engineering. Masters degree preferred.
• • 4+ years experience required.

Additional Skills:

• Sterile barrier system packaging experience is strongly preferred.
• Medical device packaging design preferred. Experience in highly regulated industry
• Knowledge of sterilization methods and design requirements for medical device packaging is preferred
• Demonstrate a strong working knowledge of standardized package testing and good working knowledge of regulatory requirements, examples: ISO-11607, ASTM D4169, etc
• Successful work experiences with different packaging materials such as - Tyvek, or HIPS, or PETG, or Polycarbonate, or Polyolefins, or co-ex films as well as good knowledge of material forming processes such as thermoforming, or injection molding, or extrusion/extrusion blow,
• Ability to develop and execute protocols for packaging design, process validation and shelf life studies; source, purchase and qualify equipment as well as develop and validate packaging processes
• Solid technical writing skills and knowledge of documentation requirements
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships

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