What are the responsibilities and job description for the Manager Packaging Engineer position at Exactech?
Job Description
Job Description
Description
The Principal Packaging Engineer will provide Packaging Engineering and related support for New Product Development Projects and for Packaging Operations. The Principal Packaging Engineer exercises independent judgment in Packaging engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among cross functional groups, and has broad expertise or unique knowledge in Packaging Engineering. Areas of involvement include package process and design, regulatory submissions, Design History File creation and maintenance, package / case evaluation, validation, and testing, supplier support, quality control and complaint evaluation.
Key Responsibilities
- Subject Matter Expert on design input requirements for medical-device packaging components through consultation with end users.
- With End of Line Manager, sets requirements and standards for application of packaging processes and technologies at Exactech.
- Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.
- Maintains roadmap on improvements to existing packaging and labeling, processes and technologies.
- Drives resolution of manufacturing or quality related issues for Quality.
- Maintain packaging bills of material and DHF / DMR documentation.
- Proactively assesses and identifies risks and gaps within packaging program. Is responsible for identifying necessary improvements to stay relevant to industry and compliance standards.
- Prepare and submit written and oral communications that describe packaging and instrument case design concepts, attributes and performance, and project status.
- Define and execute package and product (where necessary) testing and validation protocols – Gage R&R, Equipment Qualification, Recipe Qualification, Distribution, Stability, Test Method Validation, Usability, etc.
- Design, develop, and implement changes to new and existing product labels, patient implant cards, Patient Information Leaflet, and instructions for use (IFUs) for use in manufacturing.
- Develop strategies for continuous improvement of the Labeling program and procedures.
- Act as subject matter expert for the business with respect to labeling design, requirements, and implementation and labeling software and effectively collaborate on labeling changes.
- Coach and mentor junior packaging engineers and align the team around packaging and operations strategic vision
Skills, Knowledge & Expertise
Education :
Experience :
Functional / Technical Knowledge, Skills and Abilities Required :
