Senior Packaging Engineer

2 days 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.

Key Responsibilities
  • Design and Development: 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.
  • Process Optimization: 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.
  • Documentation and Compliance: Processing of documentation change requests from originator to final approval, writing and executing process validation plans and reports, using sound, data- & stats-supported results, assure compliance with the requirements set forth by US FDA QSR and ISO regulations.
  • Collaboration and Communication: 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.
  • Equipment and Materials: 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.
Requirements
  • Education: Bachelor's Degree in an Engineering discipline.
  • Experience: 5-7 years previous experience in an FDA regulated industry required: medical device, pharmaceuticals, biotech, and/or life sciences; orthopedics experience preferred.
  • Skills: Excellent written and verbal communication skills, able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail, strong organizational, analytical, and time-management skills, able to self-motivate and work both independently and as part of a team.
  • Knowledge: Understanding of ISO 13485 and QSR regulations, knowledge of statistical analysis, knowledge of computer added design (SolidWorks preferred).


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