Senior Process Engineer — MedTech Automation & Validation

Cochlear

Sydney

On-site

AUD 150,000 - 190,000

Full time

6 days ago

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Job summary

Cochlear is seeking a Senior Process Engineer to drive advanced automation within a regulated manufacturing environment in NSW. The role will lead deployment projects, develop ERS, and oversee IQ/OQ/PQ validation while improving yield and process controls.

Collaboration with vendors on robotics and machine vision will be essential, with involvement in NPI and technology transfer. The position requires a Bachelor’s in Mechatronics or related field and 3–5 years in regulated manufacturing,

Qualifications

Bachelor's degree in Mechatronics Engineering or related engineering discipline is required.
3–5 years' experience in a regulated manufacturing environment (medical devices, pharmaceuticals, diagnostics, aerospace, or semiconductor).
Experience leading automation deployment projects into production environments.
Hands-on experience in process validation (IQ/OQ/PQ).
Experience developing Engineering Requirement Specifications (ERS).
Strong understanding of PFMEA and process controls.
Experience delivering process improvements and data-driven yield optimisation.
Strong stakeholder management across teams and external partners.

Responsibilities

Lead automation deployment projects from design through production implementation.
Develop equipment and process requirements, including ERS.
Execute and support process validation activities (IQ/OQ/PQ).
Drive yield improvement through data analysis, optimisation and risk management.
Collaborate with automation vendors on robotics and machine vision solutions.
Support NPI, technology transfer and continuous improvement initiatives.