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Sr. Development Engineer, Packaging

Company: Exactech
Location: gainesville
Posted on: May 3, 2021

Job Description:

The Sr Development Engineer Packaging position will generally assist designing and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.1. With direction, design and develop package or sterilization case components for new or existing products.2. 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).3. Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.4. (For Packaging Engineer) Define and execute test protocols and reports for medical-device packaging performance testing and shelf life.5. (For Case Engineer) Perform cleaning and sterilization assessments of new and modified instruments, nonsterile implants, and/or sterilization cases.6. (For Case Engineer) Working with an outside laboratory, develop, coordinate, and approve cleaning and/or sterilization testing as needed for instruments, implants, and sterilization case systems.7. (For Packaging Engineer) Define and document sterile product bills of material and shelf life.8. Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).9. Complete all Design Control activities for projects as required.10. With direction, prioritize and manage several projects simultaneously.11. Maintain and improve existing packaging or sterilization case systems.12. (For Case Engineer only) Provide design direction or feedback to other engineers and designers in terms of suitability of instrument design for reprocessing.13. 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.14. 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.15. Consult with vendors, as required, regarding the technical aspects of design and development projects.16. Lead the project team of one major and several minor projects.17. Assure timely and effective project completion according to the project plan and budget.18. Review designs for feasibility and accuracy.19. Approve drawings and specifications.20. Procure and evaluate prototypes.21. Assist in the resolution of manufacturing- or quality-related issues.22. 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.23. Perform package/case evaluations. 24. Define and execute product testing and validation protocols.25. Participate in the establishment of goals, project plans and resource requirements.26. Identify, analyze and recommend new technologies or materials for specific applications.27. Recommend project priorities based on perceived market needs.28. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.29. Know and apply the Quality System and any appropriate Federal and International standards.30. Assist and support other employees, teams, and sales personnel as necessary.Job Requirements:Education:Bachelor's Degree from an accredited institution requiredExperience: 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 have a 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 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 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% Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Exactech, Gainesville , Sr. Development Engineer, Packaging, Other , gainesville, Florida

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