Lead Manufacturing Automation Engineer (Regulated Production)

Cochlear Limited; Sydney; Hybrid; AUD 150,000 - 210,000; Full time

Job summary

Cochlear Limited in Sydney, NSW is seeking a Senior Manufacturing Process Automation Engineer to lead automation projects from design through to production in a regulated manufacturing setting.

You will develop ERS, drive validation (IQ/OQ/PQ), and push yield improvements via data analysis and process optimization while collaborating with robotics and machine vision partners. NPI and tech transfer experience is beneficial.

Qualifications

• 3-5 years' experience in regulated manufacturing (medical devices, pharma, diagnostics, aerospace or semiconductor).
• Bachelor's degree in Mechatronics Engineering or related engineering discipline.
• Experience leading automation deployment projects into production environments.
• Hands-on process validation including IQ, OQ and PQ execution.
• Experience developing Engineering Requirement Specifications (ERS).
• Strong PFMEA and risk management knowledge.
• Experience delivering yield improvements and statistical analysis.
• Strong cross-functional collaboration and stakeholder management.

Responsibilities

• Lead automation deployment projects from design through to production.
• Develop equipment and process requirements including ERS.
• Execute and support IQ, OQ and PQ validation protocols.
• Drive yield improvement through data analysis and process optimisation.
• Collaborate with automation vendors on robotics and machine vision solutions.
• Support new product introduction, technology transfer and continuous improvement activities.

Skills

Regulated manufacturing

Process validation

ERS specifications

PFMEA risk mgmt

Statistical analysis

Stakeholder management

Automation deployment

Robotics exposure

Machine vision

Python scripting

Education

Bachelor's degree in Mechatronics Engineering or related engineering discipline

Tools

PLC

HMI

Robotics

Machine vision systems

Job description

Cochlear Limited in Sydney, NSW is seeking a Senior Manufacturing Process Automation Engineer to lead automation projects from design through to production in a regulated manufacturing setting.

You will develop ERS, drive validation (IQ/OQ/PQ), and push yield improvements via data analysis and process optimization while collaborating with robotics and machine vision partners. NPI and tech transfer experience is beneficial.