Department: Manufacturing Engineering
Location: Gainesville, FL
Description
Design and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.
Key Responsibilities
- Under supervision, 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). These design inputs should take into consideration function, reliability, cost and company image.
- Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.
- Execute test protocols for medical-device packaging or sterilization cases components.
- 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.
- 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.
- 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.
- 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 Knowledge and Expertise
Education:
- Bachelor's Degree from an accredited institution required.
Experience:
- Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, basic packaging methods, packaging evaluation, packaging materials, and technical writing.
Functional/Technical Knowledge, Skills and Abilities Required:
- Must have a 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 knowledge of various software packages including Microsoft Office applications. Knowledge of CAD applications is preferred.
