Senior Packaging Engineer at ICONMA, LLC

• Oversee 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.

• BS 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.

• Packaging 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 standards
• Understanding of process improvement, quality improvement concepts
• Ability to demonstrate project management skills and experience
• ISO 9001 certification (e.g., CQA, CQE, CQIA)
• Root cause analysis & Lean/6-Sigma methodologies
• Technical, packaging design, process & product design change management, manufacturing, quality, and or operations experience, in a health care/medical company considered a plus.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

M:(804) 915-9602