Description

You will lead sterilization qualification, validation studies, and packaging development for medical devices in Brooklyn Park, MN.

Responsibilities

• Design and perform Sterility Assurance Assessments and sterilization qualification studies.
• Coordinate terminal sterilization methods including ethylene oxide and gamma/E-Beam irradiation.
• Develop, review, and approve packaging component specifications, drawings, design history files, and risk assessments.
• Lead microbiology lab activities for Test method validation for Pyrogen Testing per USP Standards.
• Manage testing activities with contract laboratories and ensure compliance with ISO 13485, ISO 11135, and ISO 11137.

Required Skills

• 5+ years of experience in sterilization, packaging, and validation engineering.
• Proficiency with DFMECA, FMEA, and DOE.
• Statistical analysis experience using Minitab and ANOVA.
• Working knowledge of ISO 14971, 21CFR 820, and ISO 11607.
• Experience with DMR, DHR, PFMEA, CAPA, and FDA inspection requirements.
• Knowledge of MDR and GMP standards.
• Experience in cleanroom operations and sealing process characterization.

Preferred Skills

• Experience preparing documentation using Good Documentation Practices (GDP).

Key Skills

Education

Any Graduate