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Senior Packaging Engineer

Company: LHI Talent
Location: Virginia Beach
Posted on: January 15, 2022

Job Description:

As the Senior Packaging Engineer, you will support all labeling and packaging related activities with respect to design, qualifications, and development of processes and procedures for medical device packages as well packaging associated with the shipping and distribution of product. This role will be responsible for maintenance and development of all packaging to include labeling, material selection, sterilization methods, and validating of the packaging system. Will serve as division expert and interact with the project team members and suppliers involved in the packaging development process.

What you'll do:

  • Departmental Leadership: Perform project leadership responsibilities for assigned packaging process changes, labeling and packaging design, new packaging equipment, testing protocols and reports.
  • Project Management: Work with internal stakeholders and suppliers to design and source equipment and materials necessary for new product launch and continuous improvement.
  • Validation Protocols: Write qualification & validation protocols and reports for packaging, shelf-life studies and product sterilization that conform to FDA and ISO standards.
  • Quality: Investigate assigned packaging complaints, conduct associated root cause analysis and facilitate effective corrective actions.
  • Provide Expertise on Sterilization: Provide Subject Matter Expertise to internal stakeholders related to product sterilization.

    What you'll bring (Minimum Requirements):
    • Bachelor's Degree in Engineering; Master's Degree preferred.
    • 8 years in Packaging Experience; 10 years preferred.
    • 3 years Medical Device manufacturing experience in a related industry required; 5 years preferred.

      These would be nice too (Knowledge Skills and Abilities):
      • Working knowledge of regulatory testing requirements for packaging and sterilization: ISO 11607 part 1&2; Familiarity with AATB standards preferred
      • Working knowledge of labeling regulations, US and International: 21 CFR 1271.250, 21 CFR 1271.370, 21 CFR 801, 21 CFR 830, Familiarity with AATB standards preferred
      • Computer skills: Microsoft Outlook, Word, Excel, and PowerPoint; Solidworks, MiniTAB, JMP experience preferred.
      • Project Management: MS Project experience; able to manage project activities and meet deadlines as required including the use of appropriate quality and design control tools and methods; able to present project information and data to project team and management.
      • Critical Thinking: Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems; able to apply Failure mode and effects analysis (FMEA) and root cause analysis techniques; Able to lead Failure Mode and Effects analysis (FMEA), root cause analysis, and/or complaint investigations experience preferred.
      • Data Analysis: Uses mathematics and engineering principles to solve problems; uses statistics and design of experiment tools to draw conclusions.
      • Team: Able to work collaboratively in a team environment and coordinate multiple activities with a wide variety of disciplines within the company; open to others' ideas; able to lead project teams of technical staff.
      • Communication sklils: Excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within the organization.

        Communication & Presentation: Able to communicate conclusions and recommended path; able to present complex information to peers and nontechnical leadership; able to describe and convince decision makers on recommended path; able to deliver a formal presentation

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Keywords: LHI Talent, Virginia Beach , Senior Packaging Engineer, Engineering , Virginia Beach, Virginia

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