Engineer - Packaging Project Manager

Date: Nov 21, 2022

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 54818 
Title: Engineer - Packaging Project Manager 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

 

 

 

 

Arthrex, Inc. is a global medical device company leader in new product development and medical education. Arthrex is actively searching for a Project Manager for the Packaging Engineer team at our corporate office in Naples, FL They will provide Packaging Engineering support to coordinate, oversee and participate in non-MPI related packaging engineering projects to successfully complete packaging initiatives that are typically not related to new MPI product development support.  This can include redesign of packaging constructs and subsequent validation and verification activities associated with design qualification, shelf-life testing, and materials qualification. The ideal candidate will need seven or more years of highly regulated industry experience along with project management experience and a bachelor’s degree in Engineering. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities:

  • Create project Work Breakdown Structures to accomplish assigned packaging support projects.
  • Determine project timelines, durations, dependencies, and overall support requirements.
  • Create project schedules and maintain them in project management software tools.
  • Maintain project schedules by monitoring project progress, coordinating activities, and resolving problems to enable project completion.
  • Create and maintain packaging engineering specifications utilizing CAD, 3D modeling software, or other software tools.
  • Oversee any required package testing to assure viability of packaging/product constructs for sterile and/or non-sterile barrier protection.
  • Generate protocols, test reports and engineering adoptions, and support maintenance of test documentation per use of Arthrex documentation system per quality standards.
  • Ensure essential packaging development activities are completed prior to packaging design transfer activities.
  • Support Packaging Engineering activities related to CAPA findings.
  • Maintain packaging related BOM information and generate Engineering Change Orders (ECOs) in support of new additions, revisions, or other maintenance.

 

Education and Experience:

  • B.S. in Engineering required, preferably in Packaging Engineering
  • Minimum of 7 years’ experience in an FDA regulated Packaging Design and Development environment, or within Manufacturing environment required.
  • Educational background in Chemical Engineering, Materials Science or Polymer Science is preferred.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Full knowledge of industry best practices and application of principles, concepts, and standards.
  • Able to coordinate global changes that affect large numbers of technical document files.
  • Able to identify, initiate and implement process improvement suggestions.
  • Knowledge of test methods used to validate component / packaging performance.
  • Experience with project planning and project management.
  • Strong interpersonal collaboration skills and ability to influence others without authority.
  • Able to define strategy and develop contacts necessary to complete challenging projects.
  • Proficient computer skills, including Microsoft Office applications, CAD drawing tools, etc.
  • Ability to be self-directed and flexible and work in a fast-paced and quickly changing global team environment.
  • Advanced knowledge of packaging validation process as required by quality and regulatory standards.
  • Ability to research new packaging materials and suppliers for manufacturing process improvement and and/or cost reductions.
  • Advanced ability in reviewing and approving technical documentation from external packaging subcontractors as well as writing and approving technical documentation internally.
  • Proficient at creating packaging procedures and providing training on procedures.
  • Able to specify and communicate design, process, or other packaging related improvements with Arthrex manufacturing and contract packaging personnel.

 

Machine, Tools, and/or Equipment Skills:

  • PC and various data, text and graphics software programs including Microsoft Office and CAD design software.
  • Knowledge of PLM system data entry and maintenance to meet Engineering Documentation requirements.

 

 

 

 

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


Nearest Major Market: Naples

Job Segment: Package Design, Project Engineer, Project Manager, Business Process, Medical Device Engineer, Manufacturing, Engineering, Technology, Management