Senior Compliance Engineer

ResMed • San Diego, CA

21h

About The Position

The Digital Engineering Product Development organization at Resmed is seeking a Senior Compliance Engineer to help develop SaMD (Software as a Medical Device) and health software applications for Resmed customers and patients. In this role, you will work closely with software engineering teams to shape the design of software products and the development process to ensure compliance with applicable standards and regulations. You will serve as the primary expert on medical device and cybersecurity regulatory requirements, ensuring products are safe, effective, and secure for regulators and customers. Resmed, a global leader in health technology with a 30-year history of innovation, is committed to pioneering technology that empowers millions of people in over 140 countries to live happier, healthier lives. The company's AI-powered digital health solutions, cloud-connected devices, and intelligent software aim to make home healthcare more personalized, accessible, and effective. Resmed fosters a supportive, diverse, and inclusive culture, encouraging individual expression and innovation.

Requirements

• BS/MS in any engineering or scientific discipline
• At least 4-5 years of working in the medical device or pharmaceutical industry, preferably in medical device product development
• At least 3-5 years of experience in audits with criteria such as ISO 13485, EU MDR, MDSAP, HDS, SOC2, HITRUST and other regulatory frameworks
• Proficiency in producing technical analysis/reports, including ability to learn about and understand clinical pathways
• Thorough understanding of medical device regulations and standards
• Solid technical knowledge of the software development lifecycle and common industry tools and methods
• Basic familiarity with privacy laws (EU GDPR, CCPA, HIPAA)

Nice To Haves

• Computer science degree preferred

Responsibilities

• Acting as primary SME (Subject Matter Expert) in internal and external audits for your assigned products
• Creating the Risk Management Plan and performing safety and security risk analysis in collaboration with the Software Engineering and Medical Affairs teams
• Managing product requirement specifications and traceability matrices
• Leading technical design reviews for new product introductions and product updates
• Producing robust release documentation to meet change management requirements
• Performing post-market risk assessments on product defects and incidents
• Evaluating third party software libraries and tools for inclusion in our software development
• Drafting gap analyses to new or updated regulations and standards
• Revising QMS procedures to improve compliance or efficiency of our processes

Benefits

• A supportive environment that focuses on people development and best practices
• Opportunity to design, influence, and be innovative
• Work with global teams and share new ideas
• Be supported both inside and outside of the work environment
• The opportunity to build something meaningful and seeing a direct impact on people's lives
• A culture driven by excellence helps you not only meet your goals, but also create new ones
• A diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees