Senior Packaging Engineer

Our Client, a medical device and healthcare organization, is looking for an experience Sr. Packaging Engineer in Lake Forest, IL.

ResponsibilitiesOversee and manage complete packaging development process, including the creation of packaging designs, prototype development, and performance testing.

Troubleshoot new and existing packaging problems involving designs, materials and processes and provide creative, timely, and cost-effective solutions.

Analyze engineering drawings and specifications of product to determine physical characteristics of item, special handling, environmental and safety requirements, and types of materials required for packaging and handling.

Establish standards and guidelines for supplier evaluation.Evaluate and select packaging suppliers / vendors; periodically conduct vendor reviews.

Must be able to manage multiple projects simultaneously.Work closely with supply chain to optimize packaging supply base for cost, lead time, quality, regionalization, standardization, supply assurance, and compliance with customer, regulatory, and internal requirements.

Participate in product introduction teams, to deliver new products to market on time within approved budget.Work with operations functions to ensure that the packaging designs are optimized for manufacturability.

Develop and implement comprehensive test plans to ensure that packaging exceeds internal and external customer specifications.

Specify and recommend efficiency tools and test methods to develop and validate packaging designs.Integrate multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs.

Uses engineering principles to conduct technical investigations involved with the modification of material, component, or process specifications and requirements.

Create and maintain packaging engineering specifications and technical drawings / Write, review, and approve engineering protocols and reports for engineering, characterization and design verification tests.

Provide support for packaging engineering related CAPA’s.Responsibility includes mentoring and developing other members of the packaging team as well as cross training to expand knowledge in other cross-functional teams.

Write, review, and approve packaging test protocols, reports (familiarity with ASTM D4169 is required), and specification.

Engage in failure investigations and mitigation efforts to improve packaging design.RequirementsBS in packaging engineering degree or relevant engineering degree.

4-8 years related experience.Sufficient knowledge of packaging and engineering expertise to write technical rationales justifying deviations or excursions when implementing packaging design changes.

Knowledge of labels, primary packaging, secondary packaging (carton and corrugated), and shippers is needed.Familiarity with cold chain shipping tests (ISTA 7E / 7D) is a plus.

Knowledge of regulations and standards affecting IVDs and Biologics.Applies engineering technical knowledge for specified engineering discipline.

Preferred RequirementsPackaging Material experience in corrugate / carton board, labeling / decoration, with rigid plastics and flexible films.

Oversee and manage complete packaging development process, including the creation of packaging designs, prototype development, and performance testing.

Experience in healthcare, medical device or pharmaceutical industry.Experience and knowledge of design control process (21 CFR 820, ISO 13485) and risk management process including FMEAs.

Knowledge and understanding of medical device requirements (e.g. EUMDR, ), packaging design validation standards (ISO, ASTM, ISTA, DOT, IMDG, IATA etc.

drafting and specification standardsUnderstanding of process improvement, quality improvement conceptsAbility to demonstrate project management skills and experienceISO 9001 certification (e.

g., CQA, CQE, CQIA)Root cause analysis & Lean / 6-Sigma methodologiesTechnical, packaging design, process & product design change management, manufacturing, quality, and or operations experience, in a health care / medical company considered a plus.

Why Should You Apply?Health BenefitsReferral ProgramExcellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

Kshitiz PandeyM : (804) 915-9602