Senior Packaging Engineer

3 weeks ago

Wilmington, Massachusetts, United States restor3d Full time
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.

Key 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
Requirements and Qualifications
  • 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

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