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Senior Packaging Engineer in Naples, FL ,  at Arthrex

Date Posted: 11/16/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/16/2018

Job Description


Requisition ID:
41409
Title:
Senior Packaging Engineer
Division:
Arthrex, Inc.
Location:
Naples, FL

Main Objective:

Provides packaging engineering and related support to Design Engineering and when required, contract packaging suppliers.  Determine and administer changes to improve overall package performance and/or cost reduction. Support and assist the companies  packaging objectives.

Essential Duties and Responsibilities:

  1. Using a CAD program, assist in the design and development of packaging components for medical devices as required per quality standards.
  2. Create  and maintain Packaging Instruction documents that serve to illustrate the expected final outcome for manufacturing and assembly processing of finished devices to assure a match with design intent.
  3. Create and maintain packaging engineering specifications utilizing CAD or 3D modeling programs for new and existing components.
  4. Develop and oversee Instrument Case development projects in support of Design Engineering projects.  When the case is a standalone project, the Packaging Engineer will be the role of Project Manager for the project.
  5. Oversee Design Verification and Validation activities for Instrument Case components.
  6. Support product design changes to develop and improve existing products that affect existing packaging.
  7. Oversee any required package testing to assure viability of packaging/product construct and sterile barrier protection. This includes generating protocols, test reports, and engineering adoptions and maintenance of test documentation within Agile PLM and/or other approved documentation system per quality standards.
  8. Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits.
  9. Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance.
  10. Communicate effectively with Design Teams and Contract Suppliers using project management tools, written, and verbal communication.

Knowledge

Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices.

Reasoning Ability

Develops solutions to a variety of complex problems.  May refer to established precedents and policies.

Discretion/ Latitude

Work is performed under general direction.  Participates in determining objectives of assignment.  Plans, schedules, and arranges own activities in accomplishing objectives.  Work is reviewed upon completion for adequacy in meeting objectives.

Skills

•             Advanced capabilities in designing complex packaging designs and packaging instructions using a CAD program (AutoCAD or Solidworks) required.

•             Advanced knowledge of researching new packaging materials and suppliers for manufacturing process improvements and/or cost reductions.

•             Able to lead DHF projects for Instrument Cases and Packaging only projects

•             Able to Lead Global Packaging Projects for design and/or packaging process improvements.

•             Advanced knowledge of packaging validation processes.

•             Advanced ability of writing technical documentation in addition to approving technical documentation for junior engineers.

•             Able to coach and mentor, and supervise junior engineers on packaging related processes.

•             Ability to generate work procedures related to package testing, specifications, etc.

•             Advanced knowledge of design and manufacturing processes and ability to incorporate improvements into designs

•             Advanced communication skills.

•             Ability to coordinate with manufacturing suppliers and contract packagers to provide process improvements and clarify device specifications

•             Effectively support and participate in FDA and International audits in support of packaging requirements.

•             Knowledge of MS Office required.

Education/

Experience

B.S. required preferably in Packaging (science or engineering), Manufacturing or Mechanical Engineering

Minimum of 7 Yrs. experience in Packaging Design and Development or Manufacturing

Medical device packaging or manufacturing environment preferred


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