Senior Packaging Engineer
4 weeks ago
Our client, a medical device and healthcare organization, is seeking an experienced Senior Packaging Engineer to join their team in Lake Forest, IL.
Key Responsibilities:
- Oversee and manage the complete packaging development process, including design creation, prototype development, and performance testing.
- Troubleshoot new and existing packaging problems, providing creative, timely, and cost-effective solutions.
- Analyze engineering drawings and specifications to determine physical characteristics, special handling requirements, and types of materials needed for packaging and handling.
- Establish standards and guidelines for supplier evaluation and selection.
- Work closely with supply chain to optimize packaging supply base for cost, lead time, quality, regionalization, standardization, and compliance with customer, regulatory, and internal requirements.
- Participate in product introduction teams to deliver new products to market on time within approved budget.
- Develop and implement comprehensive test plans to ensure 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.
Requirements:
- 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.
Preferred Requirements:
- Packaging material experience in corrugate/carton board, labeling/decoration, with rigid plastics and flexible films.
- 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.
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