Packaging Engineer

• Demonstrated experience with validation (IQ/OQ/PQ), distribution testing, sterilization compatibility, and UDI/serialization.
• Hands on with cartoners, case packers, labelers, printers, and vision systems; familiarity with MES/serialization (L3/L4) integrations.
• Secondary packaging and coordinate primary packaging across R&D, Quality, Regulatory, Operations, and Suppliers. He/she will drive design, validation (IQ/OQ/PQ; ISTA/ASTM), serialization/UDI, artwork management, and manufacturing enablement.
• Working knowledge of risk management (ISO 14971), sampling plans (ANSI/ASQ Z1.4), and material qualification methods.
• ISO 13485/21 CFR 820/EU MDR experience; ISO 11607 familiarity; hands on with cartoners/labelers/vision; proven validation leadership; excellent stakeholder communication.
• ISO 11607 1/ 2 (packaging for terminally sterilized medical devices) for primary barrier systems & validation alignment.
• ISTA/ASTM distribution tests (e.g., ISTA 3A/3E, ASTM D4169, D4332, D4728, D5276) for shipping performance.
• Labeling/IFU and language management practices for global markets.

BS/MS in Packaging, Mechanical, Materials, Biomedical, or related field.

Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)

The expected salary range for this position is between $60,000 to $1,00,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.