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    Sr. Development Engineer Packaging - Gainesville, United States - Exactech

    Exactech
    Exactech Gainesville, United States

    4 weeks ago

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    Description

    Job Description

    Job DescriptionDescriptionDesign and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.
    Key Responsibilities
    • With direction, design and develop package or sterilization case components for new or existing products.
    • Define the design input requirements for medical-device packaging or sterilization case components through consultation with end users and other stakeholders (e.g, nurses, Sales, Marketing, Development, Quality, Manufacturing and Distribution personnel).
    • Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.
    • Define and execute test protocols and reports for medical-device packaging performance testing and shelf life.
    • Define and document sterile product bills of material and shelf life.
    • Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
    • Complete all Design Control activities for projects as required.
    • With direction, prioritize and manage several projects simultaneously.
    • Maintain and improve existing packaging or sterilization case systems.
    • Apply sound engineering problem-solving techniques to package/case development and maintenance tasks including design, statistical analysis, material selection, inspection requirements and manufacturing process requirements.
    • Prepare and submit written and oral communications that describe package/case design concepts, attributes and performance, and project status. Areas of involvement include 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, as required, regarding the technical aspects of design and development projects.
    • Lead the project team of one major and several minor projects.
    • Assure 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.
    • Assist in the resolution of 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.
    • Define and execute product testing and validation protocols.
    • Participate in the establishment of goals, project plans and resource requirements.
    • Identify, analyze and recommend new technologies or materials for specific applications.
    • Recommend project priorities based on perceived market needs.
    • Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.
    • Know and apply the Quality System and any appropriate Federal and International standards.

    Skills Knowledge and ExpertiseEducation:
    • Bachelor's Degree from an accredited institution required
    Experience:
    • Minimum of 7 years of full-time medical device packaging or sterilization case development experience. This experience shall be in addition to any college internships. Relevant product development experience in other areas may be considered.
    • Must havea basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, basic packaging and/or sterilization methods, packaging/case evaluation, packaging/case materials, and technical writing.
    Functional/Technical Knowledge, Skills and Abilities Required:
    • Must have 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.
    • Must have the ability to apply parametric solid modeling and drafting conventions to design projects.
    • Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
    • Travel 5-10%
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