We are looking for a QA electronics engineer to join the team and have a key role in the implementation of our ISO 13485 compliant QMS while assisting in the development, verification & validation of electronics for use in medical devices. You’ll work with a tight engineering team as the internal lead for quality assurance and QMS implementation, supported by experienced regulatory consultants, to create products with the potential to impact millions of lives. 

About ResusRight:

ResusRight is a young Australian MedTech start-up with a mission to save newborn lives by improving the way we resuscitate infants. Based out of Sydney, ResusRight was founded in early 2020 by a group of clinicians and PhD researchers working on the leading edge of neonatal intensive care medicine. Our vision is that no baby should die or be left with a preventable disability at birth. We believe in the power of innovative technology to empower clinicians and change the lives of babies for the better. Having just raised a seed round, ResusRight is hiring to expand capabilities and looking for mission-driven people to join us on our journey to save lives. 

What We Do:

Every year around the world 10 million newborns require help to start breathing. Of these, 1 million babies die and 1 million babies develop a permanent disability due to a lack of oxygen at birth. Our products aim to optimise the process of resuscitation by helping clinicians resuscitate better. Our goal is better outcomes for the vulnerable babies that need help in their first moments of life.

In this role you will:

• Play a crucial role in the development of ResusRight’s Quality Management System.
• Work with the engineering team across different subsystems to design and validate different testing methods, procedures, and equipment.
• Support the design, development and testing of microcontroller-based hardware for life-changing medical devices.
• Interact with all teams to help identify and address potential process quality issues.
• Support risk assessments & hazard analysis across all areas of product development.
• Steer products along the regulatory pathway from concept through to regulatory submission across multiple markets.

About You:

• Bachelor’s Degree or higher in Biomedical, Electrical, Mechatronic Engineering (or equivalent).
• Minimum 2 years’ experience working under an ISO 13485 Quality Management System.
• Knowledge of implementation and operation of ISO 138485 and FDA CFR 21 part 820.
• Experience designing and developing electronics from set requirements.
• Comfortable working autonomously, filling knowledge gaps and tackling tough problems.
• Passionate about solving high-impact real world problems.
• Detail-oriented and meticulous with your work.
• Enjoy streamlining processes and finding the optimal way to do things.

Nice-to-haves:

• Experience with Python, C# or other languages for PC scripting.
• Knowledge of IEC 60601-1.

What we offer: 

• Rewarding, impact-focused work - we have a vision that no baby should die or be left with a preventable disability at birth and are working every day to make that happen.  
• Huge amount of opportunity for personal growth - this role has substantial scope to take on extra responsibility and taking initiative is highly encouraged.
• An inclusive and friendly work environment. 
• A fast-paced environment where your contribution will be directly linked to business outcomes. 
• Offices in Darlington and happy to discuss flexible work arrangements.

If this sounds like you, please get in touch! Click ‘Apply’ to submit your CV and cover letter or alternatively contact hello@resusright.com for more information. ResusRight is committed to supporting a safe work environment and diversity in the workplace.