Senior Medical Electronics Engineer - CAPA & Safety

Cook Medical Inc.; Brisbane; On-site; AUD 120,000 - 170,000; Full time

Benefits offered by this job

Quarterly bonus

Top hospital private health cover

Annual leave loading

Subsidised cafeteria

Wellness room

Prayer room

Onsite parking

Job summary

Cook Medical is seeking a Senior Electronic Engineer to diagnose, assess and resolve hardware, firmware and networking issues across electromedical and reproductive health devices. You will verify design changes, transfer to manufacture, and support risk management in a regulated environment.

You will report to the Manager – Post Market Engineering and collaborate with a cross‑functional team to evolve processes, maintain quality systems, and ensure compliance with medical device standards.

Qualifications

• Bachelor’s degree or equivalent in Electronic Engineering.
• Experience with design controls and risk management.
• Familiarity with IEC 60601-1 or similar standards.
• Experience in the medical devices industry.
• Strong technical writing and documentation skills.

Responsibilities

• Manage supply chain related design change activities for electromedical devices.
• Lead or support CAPAs and corrective actions.
• Review product performance and safety, with root cause analysis.
• Manage engineering projects with external parties.
• Communicate analyses and risk assessments to stakeholders.

Skills

Design controls

Software lifecycle management

Risk management

IEC 60601-1 knowledge

Regulatory compliance

Education

Electronic Engineering degree

Job description

Cook Medical is seeking a Senior Electronic Engineer to diagnose, assess and resolve hardware, firmware and networking issues across electromedical and reproductive health devices. You will verify design changes, transfer to manufacture, and support risk management in a regulated environment.

You will report to the Manager – Post Market Engineering and collaborate with a cross‑functional team to evolve processes, maintain quality systems, and ensure compliance with medical device standards.