Senior Packaging Engineer, Medical Devices – NPI

Integra LifeSciences; Columbia (MD); Presencial; USD 82 000 - 113 000; Tempo integral

Resumo da oferta

Integra LifeSciences seeks a Packaging Engineer to lead design, development, and testing for sterile and non‑sterile medical devices, supporting NPI, sustaining, and process development.

You will collaborate with R&D, Quality, Regulatory, and Operations to ensure compliance with ISO 11607 and GMP, apply DOE and statistical methods, and drive continuous improvement while mentoring junior engineers.

Qualificações

• Bachelor degree with 5+ years of experience in medical device packaging.
• 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
• Strong knowledge of QSR, GMP, Design Controls, and packaging standards ISO 11607/ISO 13485.
• Ability to read engineering drawings with exposure to GD&T methodologies.
• Strong statistical analysis skills (DOE, ANOVA, capability analysis, histograms).
• Strong technical writing and documentation skills.
• Effective written and verbal communication across cross‑functional teams.

Responsabilidades

• Lead packaging design, development, and improvements for sterile and non‑sterile devices.
• Ensure packaging meets end‑user, manufacturability, regulatory, and sustainability requirements.
• Collaborate with R&D, Quality, Regulatory, Labeling, and Operations to drive design and validation.
• Plan and execute DOE studies, collect data, and document outcomes.
• Prepare technical reports, protocols, and packaging specifications.
• Mentor junior engineers and coordinate small project teams.

Conhecimentos

QSR & GMP & Design Controls

Statistics: DOE & ANOVA

Engineering drawings & GD&T

Cross-functional communication

Regulatory knowledge

Formação académica

Bachelor's degree

Master's degree

Doctoral degree

Ferramentas

MS Office

Descrição da oferta de emprego

Integra LifeSciences seeks a Packaging Engineer to lead design, development, and testing for sterile and non‑sterile medical devices, supporting NPI, sustaining, and process development.

You will collaborate with R&D, Quality, Regulatory, and Operations to ensure compliance with ISO 11607 and GMP, apply DOE and statistical methods, and drive continuous improvement while mentoring junior engineers.