Packaging Engineer - MedTech Mirox Project

LivaNova

City of Greater Dandenong

On-site

AUD 70,000 - 110,000

Full time

14 days+

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Job summary

LivaNova is seeking a Packaging Validation Support Engineer to deepen knowledge of medical device packaging manufacturing and validation. You will ensure activities comply with GMP, QMS, ISO 13485/11607, and applicable ASTM standards within an Australian regulatory context.

You will assist in planning tests, validate equipment and sealing processes, analyze data with Minitab, and help document validation activities while collaborating across packaging engineering, quality, and manufacturing

Qualifications

Knowledge of ISO 13485 and GMP principles and documentation control.
Experience with ISO 11607 and ASTM packaging standards.
Ability to read regulatory standards and procedures.
Experience with Minitab for data analysis.
Strong communication and collaboration in a regulated environment.

Responsibilities

Assist in planning and documenting packaging tests per ISO 11607.
Support validation activities for packaging equipment and sealing.
Collect and analyze packaging validation data.
Develop validation protocols and test cases per ISO 11607.
Support improvements to packaging workflows.
Maintain packaging validation docs per QMS.
Collaborate with packaging, quality, manufacturing, and labs to meet milestones.