Packaging Engineer, direct hire.
Salary: $80,000.00 – $100,000.00 per year
The Packaging Engineer’s primary role is to execute the development and technical transfer of medical device packaging projects, including packaging component design and testing/validation, as well as facilitating the integration of new packaging components into Production. The Packaging Engineer shall work closely with customer representatives in the packaging development and coordinating the successful execution of project/program deliverables through the LSO Project Manager. In addition, Packaging Engineer shall work closely with Production and Quality Assurance team members to ensure packages are designed for repeatability and reliability through the manufacturing process.
Essential Duties and Responsibilities:
– Conceive, design and develop packaging components and systems for medical device and/or delivery systems in accordance with customer/product specifications and quality system requirements. Converts customer needs into new product concept solutions;
– Works with vendors and customers to identify appropriate materials and components to meet packaging requirements;
– Design, order and procure components; develops prototypes of concepts and subcomponent mechanisms;
– Designs and develops tooling and fixturing required to support new products and line extensions; recommends appropriate packaging equipment to meet packaging design and material requirements.
– Conduct engineering analysis and feasibility testing of packaging components/systems to ensure proper fit and function. Key point of contact with Packaging Test Lab partners to perform Package Performance Qualifications; utilizes design concepts and analysis techniques, including but not limited to:
o Failure Mode Analysis
o Finite Element Analysis & modeling
o Geometric Dimensioning
o Statistical Analysis
o Tolerancing Analysis
o Stress/Strain Analysis
o Transportation Analysis (Packaging)
– Partner with Quality and Regulatory to conduct risk analysis and develop/execute design verification and validation activities to relevant packaging standards (IQ/OQ/PQ);
– Partner with Manufacturing to develop assembly procedures;
– Actively participates on New Product Development teams and Design Reviews;
– Maintain relationships with vendors to understand new technology development.
Education and Experience
– BS degree in Packaging or other Engineering discipline;
– 5+ years of experience relating to labeling and packaging within the medical industry (ISO 13485) is a must
– Expertise with Solidworks™ and other applicable packaging design/modeling software platforms;
– Experience relating to GDP and GMP and Quality Management Systems;
– Hands-on approach to problem solving, risk identification and resolution;
– Excellent Microsoft Office skills (Word, Excel, Project)
– Ability to work on multiple projects simultaneously/ adjust workload based upon priorities;
– Effective analytical skills with demonstrated success in problem solving;
– Secondary process experience including plastic manufacturing/thermoforming, foil/blister dispense/sealing, automation controls and hardware highly desirable;
– Hands on experience with process development and validation of sterile barrier heat sealing processes for Form/Fill/Seal, Pouch, and Tray/Lid Flows;
– Familiarity with performance of medical packaging formats and materials as relates to the sterilization process (gamma, EtO, E-Beam, etc.);
– Familiarity with heat seal tooling design and associated process development and validation.
Job Types: Full-time, Permanent