Senior Medical Packaging Engineer – NPI & Validation

Integra LifeSciences Corporation; Columbia, Northern (MD, KY); Hybrid; USD 82.000 - 113.000; Vollzeit

Zusammenfassung

Integra LifeSciences Corporation is seeking a Senior Packaging Development Engineer I to lead packaging system design for sterile and non-sterile medical devices. You will collaborate with cross-functional teams to drive packaging development, validation, and continuous improvement across the product lifecycle.

The role requires strong knowledge of QSR/GMP, ISO 11607, and DOE techniques, with hands-on experience in design controls, statistical analysis, and technical writing.

Qualifikationen

• Bachelor degree with 5+ years of experience or equivalent education and years of experience.
• Master degree with 3+ years of experience or equivalent education and years of experience.
• Doctoral degree with 0-2 years of experience or equivalent education and years of experience

Aufgaben

• Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices.
• Collaborate with R&D, Quality, Regulatory, and Operations to drive packaging design and validation across product lifecycle.
• Plan and execute DOE activities and apply statistical methods to support decisions.
• Prepare technical reports, protocols, and documentation of test results and conclusions.

Kenntnisse

QSR & GMP

Design Controls

ISO 11607

Regulatory knowledge

Reading engineering drawings

Statistical analysis (DOE/ANOVA)

GD&T basics

Technical writing

Cross-functional collaboration

Ausbildung

Bachelor degree

Master degree

Doctoral degree

Tools

Microsoft Excel

PowerPoint

Word

Minitab

Jobbeschreibung

Integra LifeSciences Corporation is seeking a Senior Packaging Development Engineer I to lead packaging system design for sterile and non-sterile medical devices. You will collaborate with cross-functional teams to drive packaging development, validation, and continuous improvement across the product lifecycle.

The role requires strong knowledge of QSR/GMP, ISO 11607, and DOE techniques, with hands-on experience in design controls, statistical analysis, and technical writing.