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Senior Packaging Engineer

2 months 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 Relationships
    • Develop and maintain strong, internal working relationships across both North and South restor3d facilities
  • Understand Engineering Department Objectives
    • Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals
  • Prioritize and Plan Work Activities
    • Prioritize and plan work activities; adapt for changing conditions
  • Initiation, Execution, and Documentation
    • Initiation, execution, and documentation of IQ, OQ, & PQ activities
  • Optimization of Manufacturing Processes
    • Optimization of manufacturing processes (5S) for Lean Manufacturing
  • Day-to-Day Cleanroom Packaging Production Support
    • Day-to-day Cleanroom packaging production support activities such as NCMRs and CAPAs
  • Documentation and Process Validation
    • Processing of documentation change requests from originator to final approval
    • Writing and executing process validation plans and reports, using sound, data- & stats-supported results
  • Statistical Tools and Material Evaluations
    • Using Statistical tools for alternative material evaluations and validations projects
  • Material Handling and Control System
    • Support of material handling and control system
  • Time Studies and Process Flow Mapping
    • Help conduct time studies and process flow mapping
  • Compliance and Regulatory Requirements
    • 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
  • Collaboration and Project Success
    • Work cooperatively with process development, quality, manufacturing, regulatory, and marketing to ensure project success
  • Documentation and Capital Equipment Recommendations
    • 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
  • Project Team Participation
    • Participation on project teams as a contributor bringing proactive solutions and execution
  • Other Responsibilities
    • Other responsibilities as assigned
Qualifications and Experience

Required Skills:

  • Excellent Communication Skills
    • Excellent written and verbal communication skills
  • Attention to Detail and Time Management
    • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
  • Quality and Analytical Skills
    • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
  • Organizational and Analytical Skills
    • Strong organizational, analytical, and time-management skills
  • Self-Motivation and Teamwork
    • Able to self-motivate and work both independently and as part of a team
  • Regulatory Knowledge
    • Understanding of ISO 13485 and QSR regulations
  • Statistical Analysis and Computer-Aided Design
    • Knowledge of statistical analysis
    • Knowledge of computer added design (SolidWorks preferred)
  • Root Cause Analysis and Problem-Solving
    • 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
    • Bachelor's Degree in Packaging Engineering
  • Previous Experience in FDA Regulated Industry
    • 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
    • Experience in EO and VHP Sterilization modalities
  • Experience in Cleanrooms and Controlled Environments
    • Experience working ISO Class Cleanrooms or Controlled Environments
  • Documentation and Process Development
    • Prior experience documenting manufacturing processes and creating Work Instructions and Standard Operating Procedures for a high-volume production floor
  • Just-in-Time Manufacturing and Prototype Development
    • Prior experience in just-in-time manufacturing or prototype development preferred
  • Software Skills
    • Working knowledge of MS Word, Project, PowerPoint, and Excel, AutoCAD or SolidWorks preferred

Preferred education and experience:

  • Master of Engineering Degree
    • Master of Engineering Degree strongly preferred

Physical Requirements:

  • Prolonged Sitting and Computer Work
    • Prolonged periods sitting at a desk and working on a computer