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MANAGER PACKAGING ENGINEERING
at ExacTech, inc.
Duties and Responsibilities (Key Deliverables):
1. Coordinate and supervise the activity of the engineering personnel on the subset of the E&D Team that he/she is responsible for.
2. Recommend and direct personnel activities such as recruiting, hiring, and salary adjustments.
3. Complete performance evaluations for personnel that he/she supervises.
4. Develop training plans for personnel and document all training.
5. Coach and support personnel in the execution of his/her duties.
6. Develop yearly team and employee accountability plans to support company objectives.
7. Provide leadership and team direction for other engineering personnel in the development and maintenance of orthopedic implants and instruments.
8. Provide mentorship and professional guidance to junior members of the engineer and development team.
9. Prioritize and manage several packaging projects simultaneously.
10. Lead the project team of several new packaging projects.
11. Maintain and improve existing packages.
12. Provide design, engineering, and analysis direction to other packaging engineers and designers.
13. Design and develop package components for new or existing products.
14. Define the design input requirements for medical-device packaging components through consultation with surgeons, nurses, Sales, Marketing, Development, Quality, Manufacturing and Distribution personnel.
15. Prepare specifications for the raw materials, components, processes and reports for medical-device packaging components.
16. Define and execute test and validation protocols for medical-device packaging components.
17. Apply sound engineering problem-solving techniques to package development and maintenance tasks including design, statistical analysis, material selection, inspection requirements and manufacturing process requirements.
18. Prepare and submit written and oral communications that describe package design concepts, attributes and performance. Areas of involvement include regulatory submissions, Design History Files, package evaluation, package validation and testing, manufacturing or supplier support, quality control and packaging complaint evaluation.
19. Consult with vendors, as required, regarding the technical aspects of packaging design and development projects.
20. Oversee the management of the project teams for all packaging projects.
21. Assure timely and effective packaging project completion according to the project plan and budget.
22. Participate in regulatory audits to represent the packaging engineering function.
23. Review packaging designs for feasibility and accuracy.
24. Approve packaging drawings and specifications.
25. Procure and evaluate packaging prototypes.
26. Assist in the resolution of manufacturing- or quality-related issues.
27. Study and recommend improvements to existing packaging and processes. This entails staying “up to date” on emerging material and sterilization technologies.
28. Perform package evaluations. This may be accomplished by attending seminars, classes and industry meetings.
29. Define and execute product testing and validation protocols.
30. Participate in the establishment of goals, project plans and resource requirements.
31. Identify, analyze and recommend new technologies or materials for specific packaging applications.
32. Recommend project priorities based on perceived market needs.
33. Establish, develop and maintain strong working relationships with all necessary personnel to ensure smooth product design, development and commercialization.
34. Attend seminars, classes and industry meetings that contribute to professional development.
35. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.
36. Know and apply the Quality System and any appropriate Federal and International standards.
37. Assist and support other employees, teams, and sales personnel as necessary.
Education: Bachelor’s Degree from an accredited institution required; Master’s Degree preferred
• Minimum of 7 years of full-time medical device packaging development experience. This experience shall be in addition to any college internships. Relevant product development experience in other areas may be considered.
• Must have successfully completed a minimum of three major projects and three minor projects (e.g., line extensions, packaging system modifications, etc.) of sufficient complexity. During the execution of these projects, must have been involved all aspects of the packaging development process. A minor project involves the modification, adaptation or extension of an existing packaging component or system.
• 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 excellent communication (verbal & written) and organizational skills.
• Must have excellent interpersonal skills and must be able to work effectively in a team environment.
• Must be creative and have the ability to independently apply theoretical technical principles to packaging design.
• Must have a practical working knowledge of medical-device packaging systems, packaging evaluation techniques/methods, engineering drawing interpretation, packaging manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and the materials and methods used in their packaging.
• Must have the ability to apply parametric solid modeling and drafting conventions to packaging design projects.
• Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
• Must have the ability to prioritize and manage several projects simultaneously.
• Travel 5-10%