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Sr Packaging Engineer

LanceSoft Inc.
Brooklyn Park, Minnesota, 55428, United States
November 05, 2018


JOB TITLE: Contract Packaging Engineer

Duration: 12+ Month Contract

DEPARTMENT: Packaging Engineering (CS)

REPORTS TO: Packaging Engineering Manager

Position Description

The Packaging Engineer will collaborate on process continuous improvement and product commercialization cross-functional project teams. They are responsible for the design, development, and support of package systems and processes for sterile medical devices including components, assemblies, and end items. They are responsible for demonstrating high-level performance that delivers high-quality packaging on schedule, which meets customer, patient, and regulatory needs.

Position Responsibilities

• Development of packaging components, and assemblies for sterile (sterilized by Ethylene Oxide, Steam, Gamma methods), medical products in support of new and existing products.

• Provide technical recommendations and implement changes in the packaging process and materials.

• As requested, collaborate with Packaging to identify and implement best practices, packages, and processes.

• As requested, participate on cross-functional, cross-site project teams focusing on packaging, technology and process improvements.

• Apply knowledge of FDA and ISO requirements related to packaging, ensuring robust package verification.

• Experienced with IQ/OQ/PQ as part of packaging processes.

• Draft technical documentation including package design testing protocols and reports for verification and release of package designs.

• Manage shelf life (accelerated and real-time) and biocompatibility testing for new packaging material combinations.

• Serve actively in the identification of suppliers, testing and approving materials, including liaison with vendors.

• Ensure personal understanding of all quality policy/system items that are per assigned training curriculums. Follow all work/quality procedures to ensure quality system compliance.

• Frequent collaboration with other departments and customers.

• Self-directed and works under minimal supervision.

• As requested, provide guidance/mentor Associate and Package Engineers with the Packaging Development organization.

Basic Qualifications

• Bachelor of Science in Packaging with 4+ years of job-related experience; or MS in Packaging with 2+ years of job-related experience.

• 2+ years of packaging experience.

Desired/Preferred Qualifications

• 5+ years medical device packaging experience (or relevant medical device experience outside of packaging).

• Experience working with ISO, ASTM, and standards related to packaging.

• Working knowledge of project management methodologies.

• Demonstrated initiative; results oriented; willingness and ability to institute change.

• Process orientation and strong interest in continuous improvement.

• Excellent communication (written and verbal) skills.

• Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of multiple stakeholders. Makes timely decisions in the face of risk and uncertainty.

• Medical device industry experience.

• Demonstrated strong analytical skills and judgement.