Packaging Engineer

About the role

LivaNova is seeking a Packaging Engineer to support medical device packaging projects, ensuring compliance with GMP, QMS, and relevant regulatory standards. The role involves planning, executing, and documenting packaging tests and validation activities.

Key responsibilities

• Assist in planning, execution, and documentation of packaging tests per ISO 11607 and ASTM standards.
• Support development and documentation of packaging validation, including equipment, sealing processes, and transport/stability simulations.
• Collect, analyze, and interpret validation data using statistical methods.
• Develop validation protocols, test plans, and test cases aligned with ISO 11607‑1 and ISO 11607‑2.
• Design and improve manufacturing and testing tools to enhance efficiency and repeatability.
• Identify and implement improvements to packaging workflows and materials.
• Maintain validation documentation in compliance with LivaNova’s QMS.
• Collaborate cross‑functionally with engineering, quality, manufacturing, labs, and project teams.

Required profile

• Strong foundation in mechanical engineering principles applied to medical device packaging.
• Understanding of ISO 13485, GMP principles, documentation control, validation lifecycle, risk management, and data integrity.
• Working knowledge of ISO 11607 (Parts 1 and 2) and relevant ASTM packaging standards (e.g., ASTM F88/F88M, F1140/F1140M, F1929, F2052, F1980).
• Ability to read, interpret, and apply regulatory standards and internal procedures.
• Statistical analysis capability, preferably with Minitab.
• Hands‑on experience or aptitude with packaging testing equipment and production tools.

Required skills

• ISO 13485
• GMP
• ISO 11607
• ASTM F88, F88M, F1140, F1140M, F1929, F2052, F1980
• Minitab statistical software
• Siemens Solid Edge CAD
• Microsoft Office Suite
• EXACT ERP
• Packaging testing equipment (seal strength tester, burst tester, dye penetration tester, vernier calipers, micrometers, hardness testers)