Senior Electronic Engineer, Medical Devices — Post-Market & CAPA

Cook Group; Brisbane; Presencial; AUD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Quarterly bonus

Private health cover

Annual leave loading

Subsidised cafeteria

Wellness room

Prayer room

Onsite parking

Mentoring and development

Community engagement initiatives

Descripción de la vacante

Cook Medical in Australia is seeking a Post Market Engineer to diagnose software/firmware, hardware and networking issues, and verify design changes. You will work under the Manager – Post Market Engineering in a collaborative, high-performing team, applying design control and risk management practices.

Responsibilities include managing supply chain design change activities for electromedical and reproductive health devices, leading CAPAs, and reviewing performance and safety with root cause

Formación

• Tertiary Qualifications in Electronic Engineering or equivalent essential.
• Knowledge and experience in the application of design controls including software lifecycle management essential.
• Knowledge and Experience in the application of risk management techniques essential.
• Knowledge of the application of and compliance to the medical electrical device standard (IEC 60601-1) or similar product standards preferred.
• Previous experience working within a highly regulated industry, medical devices preferred
• Documentation in accordance with strict quality management systems is an essential part of this role so the applicant must have good technical writing skills and attention for detail.
• Experience working across multiple projects and disciplines with good time management and communication skills essential

Responsabilidades

• Management of supply chain related design change activities for our electromedical and reproductive health devices.
• Lead or support Corrective and Preventive Actions (CAPAs).
• Review of product performance and safety, including root cause analysis and design solutions to resolve any identified problems.
• Management of engineering driven projects or programs with external parties.
• Effective communication of technical analyses and risk assessments to cross-functional stakeholders.

Conocimientos

Design controls

Software lifecycle

Risk management

IEC 60601-1 standards

Regulated medical devices

Technical writing

Time management

Communication skills

Educación

Electronic Engineering

Descripción del empleo

Cook Medical in Australia is seeking a Post Market Engineer to diagnose software/firmware, hardware and networking issues, and verify design changes. You will work under the Manager – Post Market Engineering in a collaborative, high-performing team, applying design control and risk management practices.

Responsibilities include managing supply chain design change activities for electromedical and reproductive health devices, leading CAPAs, and reviewing performance and safety with root cause