Design Engineer, Packaging

Key Responsibilities

• Design and develop package or sterilization case components for new or existing products.
• Define design input requirements for medical-device packaging or sterilization case components through consultation with end users and other stakeholders.
• Prepare specifications for raw materials, components, and processes for medical-device packaging or sterilization case components.
• Execute test protocols for medical-device packaging or sterilization case components.
• Document sterile product bills of material and shelf life.
• Establish appropriate project plans (define tasks, dependencies, schedule, and resource requirements).
• Complete all Design Control activities for projects as required.
• Maintain and improve existing packaging or sterilization case systems.
• Apply sound engineering problem-solving techniques to package/case development and maintenance tasks.
• Prepare and submit written and oral communications describing package/case design concepts, attributes, and performance and project status.
• Involvement includes regulatory submissions, Design History Files, package/case evaluation, package/case validation and testing, manufacturing or supplier support, quality control, and complaint evaluation.
• Consult with vendors regarding the technical aspects of design and development projects.
• Afford timely and effective project completion according to the project plan and budget.
• Review designs for feasibility and accuracy.
• Approve drawings and specifications.
• Procure and evaluate prototypes.
• Aid in resolving manufacturing- or quality-related issues.
• Study and recommend improvements to existing packaging and processes or case systems.
• This entails staying “up to date” on emerging material and sterilization technologies.
• This may be accomplished by attending seminars, classes, and industry meetings.
• Perform package/case evaluations.
• Identify, analyze, and recommend new technologies or materials for specific applications.
• Define and execute product testing and validation protocols.
• Know and apply the Quality System and any appropriate Federal and International standards.

Skills

• Practical working knowledge of medical-device packaging or sterilization case systems, packaging/case evaluation techniques/methods, engineering drawing interpretation, packaging/case manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and/or instruments, and the materials and methods used in their packaging or sterilization cases.
• Knowledge of various software packages including Microsoft Office applications.
• Preferred knowledge of CAD applications.