Compliance Engineer- job post Clarius Mobile Health
Job Description
A Career at Clarius
Today, as many as 25 million medical professionals globally don’t have access to medical imaging, which is proven to improve patient care and reduce healthcare costs. That’s why we’re on a mission to make medical imaging accessible everywhere by delivering high-performance, affordable, and easy-to-use solutions powered by artificial intelligence and connected to the cloud.
By making Clarius your next career move, you’re joining a team of 140+ people who are talented, innovative, and highly collaborative. You’re also joining a community that includes thousands of physicians worldwide who use Clarius to deliver better patient care! And you’re joining a thrice-certified Great Place to Work!
Your Role
You'll own hardware compliance and product safety certification across all domains (electrical, mechanical, firmware, and software) for Clarius' handheld medical ultrasound devices. You'll be both a hands-on engineer in your area of strength and an orchestrator across domains you're less experienced in. The work spans compliance testing to global standards (IEC 60601 suite), regulatory certification (FDA, Health Canada, EU MDR, FCC, ISED/IC, CE/RED), and pre-market submissions. If you have lab experience, you'll execute testing and advise internal teams on compliance gaps. If your background is in-house engineering, you'll coordinate with external labs and manage vendors while owning documentation and regulatory strategy. Either way, you'll be the point person who knows what we have, what we need from each domain expert, and how to move products through the full compliance lifecycle to submission-ready status.
Your Responsibilities Include:
Plan, coordinate, and manage EMC compliance testing to IEC 60601-1-2 for handheld medical ultrasound devices, including pre-compliance testing, test-lab liaison, and resolution of findings.
