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About the Role

The Digital Engineering Product Development team at ResMed is seeking a Compliance Engineer to support the development of Software as a Medical Device (SaMD) and health software applications. You will collaborate with software engineering teams to ensure products and development processes meet regulatory, safety, and cybersecurity standards, playing a critical role in building trust with regulators and customers by ensuring solutions are safe, secure, and effective.

Responsibilities

Serve as the primary Subject Matter Expert (SME) during internal and external audits for assigned products.
Develop Risk Management Plans and perform safety and cybersecurity risk analyses in collaboration with Software Engineering and Medical Affairs teams.
Manage product requirement specifications and maintain traceability matrices.
Lead technical design reviews for new product introductions and product enhancements.
Prepare comprehensive release documentation to support change management requirements.
Conduct post-market risk assessments on product defects and incidents.
Evaluate third-party software libraries and tools for integration into development workflows.
Perform gap analyses against new or updated regulations and industry standards.
Update and improve Quality Management System (QMS) procedures to enhance compliance and operational efficiency.

Requirements

Bachelor’s or Master’s degree in Engineering or a scientific discipline (Computer Science preferred).
2–3 years of experience in the medical device or pharmaceutical industry, ideally within product development.
At least 1 year of audit experience involving standards such as ISO 13485, EU MDR, MDSAP, HDS, SOC 2, HITRUST, or similar frameworks.
Strong ability to produce technical analyses and reports, with an aptitude for understanding clinical workflows and pathways.
Foundational knowledge of medical device regulations and standards.
Solid understanding of the software development lifecycle (SDLC), tools, and methodologies.
No hands-on coding experience required.

Experience Level

2-3 years of experience in the medical device or pharmaceutical industry
1 year of audit experience

Education Level

Bachelor’s or Master’s degree in Engineering or a scientific discipline (Computer Science preferred)

Benefits

A supportive and collaborative environment focused on professional development and best practices.
Opportunities to design, influence, and innovate within a global health technology organization.
Collaboration with cross-functional and global teams.
A workplace that promotes both professional and personal well-being.
The chance to contribute to meaningful solutions that positively impact people’s lives.

About the Company

With a 30 year history of innovation as a global leader in health technology, ResMed knows those good ideas can come from anywhere. Innovation and imagination are integral to the way we work. We work hard to provide the opportunity for every employee to do amazing things every day as we shape the future together.
Resmed (NYSE:RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives.
Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective.
Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home.

Equal Opportunity

We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.
We commit to respond to every applicant.