Job Summary

The Packaging Engineer will be responsible for assisting with the design, selection, development, qualification, support and scale-up of production processes and equipment across different manufacturing departments.

This position develops new packaging as needed, assesses and resolves packaging problems, and works with vendors as needed.

Duties and responsibilities

Develop and maintain strong, internal working relationships across both North and South restor3d facilities
Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals
Prioritize and plan work activities; adapt for changing conditions
Initiation, execution, and documentation of IQ, OQ, & PQ activities
Optimization of manufacturing processes (5S) for Lean Manufacturing
Day-to-day Cleanroom packaging production support activities such as NCMRs and CAPAs
Processing of documentation change requests from originator to final approval
Writing and executing process validation plans and reports, using sound, data- & stats-supported results
Using Statistical tools for alternative material evaluations and validations projects
Support of material handling and control system
Help conduct time studies and process flow mapping
Assure compliance with the requirements set forth by US FDA QSR and ISO regulations
Interpret standards and FDA requirements for device packaging and validations
Apply sterilization requirements/standards to packaging design and validation
Work cooperatively with process development, quality, manufacturing, regulatory, and marketing to ensure project success
Documentation of manufacturing packaging processes and inspection criteria within the company’s documentation procedures
Evaluate and recommend capital packaging equipment to best suit the needs of the company’s selected fabrication processes
Participation on project teams as a contributor bringing proactive solutions and execution
Other responsibilities as assigned

Qualifications and experience

Required Skills:

Excellent written and verbal communication skills
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
Strong organizational, analytical, and time-management skills
Able to self-motivate and work both independently and as part of a team
Understanding of ISO 13485 and QSR regulations
Knowledge of statistical analysis
Knowledge of computer added design (SolidWorks preferred)
Ability to work independently as well as on teams to perform root cause analysis and provide solutions to the root cause.

Education and Experience:

Bachelor’s Degree in Packaging Engineering
5-7 years previous experience in an FDA regulated industry required: medical device, pharmaceuticals, biotech, and/or life sciences; orthopedics experience preferred.
Experience in EO and VHP Sterilization modalities
Experience working ISO Class Cleanrooms or Controlled Environments
Prior experience documenting manufacturing processes and creating Work Instructions and Standard Operating Procedures for a high-volume production floor
Prior experience in just-in-time manufacturing or prototype development preferred
Working knowledge of MS Word, Project, PowerPoint, and Excel, AutoCAD or SolidWorks preferred

Preferred education and experience:

Master of Engineering Degree strongly preferred

Physical Requirements:

Prolonged periods sitting at a desk and working on a computer

restor3d

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