MedTech Packaging Engineer - ISO 11607 & GMP

LivaNova PLC; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

LivaNova is seeking a packaging engineer to join our global medical device packaging team in Melbourne. You will gain knowledge of packaging manufacturing and validation processes, ensuring compliance with GMP, QMS, ISO 13485/11607 and Australian regulatory requirements.

You will assist in planning, executing and documenting tests, support validation activities for packaging equipment and transport simulations, and contribute to improvements of packaging workflows across manufacturing.

Qualifications

• Strong knowledge of ISO 13485 and GMP principles, including documentation control, validation lifecycle, risk management, and data integrity.
• Experience reading and applying ISO 11607 and ASTM packaging standards.
• Ability to read, interpret, and apply regulatory standards and internal procedures.
• Experience with statistical data analysis and generating validation reports.
• Hands-on experience with packaging testing equipment is a plus.

Responsibilities

• Assist in planning, execution, and documentation of medical device packaging tests per ISO 11607.
• Support development and validation of packaging processes and equipment.
• Collect, analyze, and interpret packing validation data using statistical methods.
• Create and maintain packaging validation documentation per QMS.
• Collaborate with packaging engineering, quality, manufacturing, and external labs to ensure timely project delivery.

Skills

Mechanical engineering principles

GMP & ISO13485 knowledge

Statistical analysis (Minitab)

Regulatory standards reading

Communication & collaboration

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Minitab

Solid Edge CAD

Excel

Exact ERP system

Job description

LivaNova is seeking a packaging engineer to join our global medical device packaging team in Melbourne. You will gain knowledge of packaging manufacturing and validation processes, ensuring compliance with GMP, QMS, ISO 13485/11607 and Australian regulatory requirements.

You will assist in planning, executing and documenting tests, support validation activities for packaging equipment and transport simulations, and contribute to improvements of packaging workflows across manufacturing.