Packaging Engineer

2 weeks ago

Wilmington, Massachusetts, United States restor3d Full time
Job Description

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

    • 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.

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