Senior Process Engineer

C01 Cochlear Limited (Australia); City of Lake Macquarie; On-site; AUD 130,000 - 170,000; Full time

Job summary

Cochlear Limited, a global leader in implantable hearing solutions, is seeking a Senior Process Engineer for our Macquarie University, NSW office. You will lead the deployment of automated manufacturing solutions, drive process improvements, and ensure validated, compliant production processes in a regulated environment.

You will collaborate with automation partners, support NPI and technology transfer, and mentor junior engineers while advancing scalable manufacturing capabilities for

Qualifications

• Bachelor's degree in Mechatronics Engineering or related engineering discipline.
• 3-5 years experience in a regulated manufacturing environment (medical devices, etc).
• Experience leading automation deployment projects into production environments.
• Hands-on process validation experience (IQ/OQ/PQ).
• Experience developing Engineering Requirement Specifications (ERS).
• Strong PFMEA and process controls knowledge.
• Experience delivering process improvements, yield optimisation, and statistical analysis.
• Strong stakeholder management across teams and external partners.

Responsibilities

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

Skills

Automation deployment

Process validation

Risk management

Stakeholder management

Statistical analysis

Python scripting

Education

Bachelor's degree in Mechatronics Engineering

Tools

PLC

HMI

Machine vision systems

Job description

Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.

The Opportunity

Cochlear has an opportunity for a full-time Senior Process Engineer based in our Macquarie University, NSW office. In this role, the successful Senior Process Engineer will provide specialised process engineering expertise to support the development, implementation and deployment of custom automation solutions within a regulated manufacturing environment. Working closely with automation partners and cross-functional stakeholders, this role will lead process improvements, support new technology introduction activities, drive validation programs and ensure manufacturing processes are capable, compliant and scalable.

Responsibilities

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

What makes this opportunity unique?

This role sits at the intersection of process engineering and advanced automation, providing the opportunity to work with robotics, machine vision and custom manufacturing technologies that directly support the production of life-changing hearing solutions. You'll have the opportunity to influence manufacturing strategy, partner with leading automation suppliers and drive innovation within a highly regulated medical device environment.

About You

Essential

• Bachelor's degree in Mechatronics Engineering or a related engineering discipline.
• 3-5 years' experience within a regulated manufacturing environment, such as medical devices, pharmaceuticals, diagnostics, aerospace or semiconductor industries.
• Demonstrated experience leading automation deployment projects into production environments.
• Hands-on experience in process validation, including IQ, OQ and PQ execution.
• Experience developing Engineering Requirement Specifications (ERS) and translating business requirements into technical solutions.
• Strong understanding of risk management methodologies, including PFMEA and process controls.
• Experience delivering process improvements, yield optimisation and statistical analysis.
• Strong stakeholder management skills with the ability to work effectively across teams and with external automation partners.

Ideal

• Experience with industrial robotics implementation and automated manufacturing systems.
• Knowledge of machine vision systems and equipment characterisation.
• Experience participating in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Familiarity with PLC and HMI-based control systems.
• Exposure to technology transfer and new product introduction (NPI) activities.
• Basic scripting capability in Python, Lua or similar languages.
• Experience coaching or mentoring junior engineers and graduates.

How we recognise your contribution

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about Life at Cochlear, visit www.cochlearcareers.com

We have provided more than 600,000 implantable devices, helping people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.