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