Senior Packaging Engineer

Job Title
Senior Packaging Engineer
Job ID
27736100
Location
Wilmington, MA, 01887 
Other Location
Description
 
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 an Engineering discipline
  • 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:
  • Bachelor’s Degree in Packaging Engineering
  • Master of Engineering Degree strongly preferred
Physical Requirements: 
  • Prolonged periods sitting at a desk and working on a computer

Option 1: Create a New Profile