Exactech
Principal Packaging Engineer
Exactech, Gainesville, FL, United States
Principal Packaging Engineer
Department: Manufacturing Engineering
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Manager Packaging & End of Line Engineering
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
Education:
Department: Manufacturing Engineering
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Manager Packaging & End of Line Engineering
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
Education:
- Bachelor's Degree from an accredited institution required; Master's Degree preferred
- Minimum of 8 years medical device packaging. Relevant product development experience in other areas may be considered
- Must understand theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, packaging methods, packaging evaluation, packaging materials, and technical writing.
- Expertise in the writing of validation/verification plans for various types of packaging testing, including but not limited to Gage R&R, development and execution of IQ/OQ/PQ documents (Equipment Qualification), Recipe Qualification, Distribution, Stability, Test Method Validation, Packaging Usability Minimum of 5 years with Good Manufacturing Practices & Lean Manufacturing in the Medical device industry preferred.
- FDA CFR 820 Quality Systems Regulations, and ISO 11607: 2022 in the medical device industry preferred or other applicable regulatory compliance.
- Must have a practical working knowledge of medical-device packaging or sterilization case systems, packaging/case evaluation techniques/methods, engineering drawing interpretation, packaging manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and/or instruments and materials and methods used in their packaging or sterilization cases.
- Must be creative and able to independently apply theoretical technical principles to packaging and process design.
- Must have knowledge of various software packages including Microsoft Office, CAD, and Statistical Analysis applications (e.g. Minitab).
- Prioritize and manage several projects simultaneously.