Senior Electronic Engineer - Medical Devices

Cook Group; Brisbane; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Quarterly bonus

Private health cover

Annual leave loading

Subsidised cafeteria

Wellness room

Prayer room

Onsite parking

Mentoring and development

Community engagement initiatives

Job summary

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

Qualifications

• 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

Responsibilities

• 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.

Skills

Design controls

Software lifecycle

Risk management

IEC 60601-1 standards

Regulated medical devices

Technical writing

Time management

Communication skills

Education

Electronic Engineering

Job description

We are passionate about making unique, quality medical devices and connecting with people to improve lives. Founded on inventing,manufacturingand delivering medical devices, we provide healthcare professionals with the tools they need to help their patients return to living.

Our commitment to innovation involves bringing new products to market and keeping existing products relevant to a changing healthcare landscape. We believe in using our business to help people and communities thrive by creating inclusive,supportiveand healthy environments.

We are proud of our history of innovative firsts and the impact we have on patients and communities. With manufacturing facilities in Australia, Europe and North America and offices in various locations around the world, we challenge ourselves tomaintaina global perspective while focusing on local impact.

Great Place to Work Certified

Oursevencorevaluesshape how we workwith patients,customersand each other.They guide the way we collaborate, supportone anotherand remain deeply connected to the impact of our work.

That'swhywe'reproud to berecognised as a Great Place to Work, based on feedback from our employees about our culture,leadershipand the pride we share in making a difference to patientsevery day.We'recommitted to creating an environment where people feel supported,connectedand valued.

Employee Benefits

• Quarterly bonus, Top Hospital Private Health Cover and annual leave loading
• Subsidised cafeteria, wellness room, prayer room and onsite parking
• Ongoing support, mentoring and professional development
• Inclusive team culture with opportunities to join our community engagement initiatives

Communitycommitment

Our communityengagementprogram reflects our commitment to creating meaningful impact beyond the workplace through community partnerships,employeevolunteeringandphilanthropy.

We focus on key areas such as community support, education, environment, health and wellbeing, and vulnerable populations.The program encourages employee involvement and helps strengthen connections with the communities in which we live and work.

Learn more about us

Visit www.cookmedical.com.au/careers

We encourage applications from Indigenous Australians, people with disability, those from diverse cultural backgrounds, people from the LGBTQI+ community and anyone else who wants to be a part of our Cook Australia family.

Overview

An exciting opportunity for you to work on projects which support Cook Medical's electromedical and reproductive health devices in the market. You will be responsible for diagnosing software/firmware, hardware and networking issues, design issues, proposing solutions, verification and validation of design changes and transferring design changes to manufacture.

Reporting to the Manager – Post Market Engineering, you will bring these skills and your design control and risk management background to a collaborative, high performing team who are constantly looking at ways to evolve and improve the way we work.

Responsibilities

• 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.

Qualifications

• 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

Candidates applying to this role must be a permanent resident or citizen of Australia.

This role is to commence as soon as possible, and shortlisting will commence immediately.