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Position title: Senior Verification and Validation Engineer

Position type: Permanent Full-Time

Location: Melbourne CBD & working from home

Our Story

4DMedical is a global medical technology company aiming to change the outcomes for patients with lung disease by revolutionising respiratory imaging and ventilation analysis. Our vision is a world in which people with lung disease have better health outcomes.

We have recently completed a successful Initial Public Offering (IPO) listing on the ASX, and we are currently in a high-growth stage of the business.

The Position 

We are looking for an experienced Senior Verification and Validation Engineer to form and lead a new, independent testing team within 4DMedical. Ultimately, you will be responsible for overseeing the V&V testing for our novel medical devices.

What can you expect as Senior Verification and Validation Engineer? 

As the Senior V&V Engineer, you will be responsible for the strategy, preparation, execution and management of 4DMedical’s V&V testing. Your team of testers will work relatively autonomously, with you providing guidance and mentorship to each member of the team.

You will feel comfortable working independently and proactively, however you will receive plenty of support from our leadership team to establish this new testing team.

The role will include:

• Leading the implementation and strategy for the V&V Team.
• Performing Verification and Validation testing in an FDA/TGA/EU/ ISO13485 regulated environment.
• Automating manual testing activities
• Manage all qualification activities, to ensure compliance to internal Quality Management System requirements and to applicable regulatory standards.
• Working with cross functional teams
• Designing and developing test protocols for new and advanced features.
• Apply experience with black box testing to plan, write test cases, test reports for Class II Medical Devices.
• Writing technical test protocols and technical reports.

Qualifications & Industry experience requirement:

• Bachelor’s Degree in Computer Science, Engineering or a directly related field.
• 5 years’ experience in leading a validation or V&V team for medical device, pharmaceutical or biotech industries.
• Knowledge of an FDA/TGA/EU/ ISO13485 quality and regulatory requirements for testing.
• Software CSV or Software Testing Experience.
• Experience with Software as a Medical Device (SaMD) or radiation emitting devices is highly regarded but not essential.

What can we offer you?

• Flexible working hours
• Attractive remuneration package and other benefits
• An opportunity for you to grow in a friendly and supportive culture

This is an exceptional opportunity to join a forward thinking, fast growing company and make a real difference.

How to Apply

Please apply via the link and submit a current CV and a cover letter which details your alignment with the requirements of the role.

4DMedical provides an inclusive work environment and embraces the diverse talent of its people.

For more company information visit our website: www.4dmedical.com

Should you have any queries regarding the position please contact the 4DMedical Recruitment Team at: recruitment@4dmedical.com