Verification And Validation Engineer

About Us:

Rapid Response Revival (RRR) is an Australian owned, Medical Device innovator. Based in Riverwood, we design, manufacture and supply automatic external defibrillators (AED’s) for multiple global markets with our priority centred around developing AED solutions that make portable defibrillation affordable, accessible and effective. We are looking for a full-time permanent, Verification and Validation Engineer to join our Engineering Support team with flexibility for hybrid work options available.

The Opportunity

Reporting to the Engineering Support Manager, the Verification and Validation Engineer will produce analysable and auditable data, converting this into strategic decision-making product intelligence to empower the wider business in support of our mission to increase the survival rate from sudden cardiac arrest around the world.

Central to your success will be your ability to collaborate with cross functional team members in engineering, marketing, research & development, manufacturing, and regulatory departments as well as external accredited test houses, and governing bodies.

Key aspects of this role:

• Establishing test procedures and documenting results that are analysable and auditable within the quality management system

• Performing verification tests to ensure compliance with industry standards and product requirements

• Performing validation tests to ensure compliance with quality expectations and user needs

• Performing investigations to explore product improvements and model the behaviour of the device and its components

• Investigating customer complaints, including measuring, and analysing data from RRR products and customer descriptions, in compliance with the Quality and Post Market Surveillance (PMS) systems

• Verifying the efficacy and effectiveness of risk controls

• Analysing test data to determine the causes of defects, failures or flaws and facilitating corrective measures

• Presenting verification test results and recommending improvements to product design and/or test procedures

• Independently reviewing engineering solutions and processes

• Showcasing RRR IP and representing the business externally in a technical capacity, including trade fairs, exhibitions, and clinical procedures

• Clear and concise documentation of complex concepts in a manner which is easily understood

About you

• Bachelor’s degree in Engineering or a related field of specialisation

• Relevant Experience in the medical industry and/or other highly regulated industries (e.g. defence)

• Experience with Quality Management System (QMS) framework

• Familiarity with ISO 9001, ISO 13485 & ISO 14971 highly desirable

• Experience with Jira Project Management tools are advantageous

• Experience with Jama software is advantageous

• Familiarity with IEC 60601 and IEC 60601-2-4 advantageous

• Self-starting, proactive attitude and ability to work independently.

• Exceptional written and verbal communication.

• Structured approach to problem solving with a continuous improvement mindset.

Why should you apply?

• Contribute to a forward-thinking, collaborative, energetic and innovative team.

• Opportunity to be part of an exciting start-up as we scale and break into new markets

• Personal interest in technology driven innovation and life saving technologies.

• Work for an Australian Manufacture, blazing a trail in the global Medical Device industry.

Apply today and make 2024 the year you become a lifesaver.

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