Compliance Engineer

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.
• Manage electrical safety testing and certification to IEC 60601-1, IEC 60601-1-11 (home healthcare environment), and IEC 60601-1-12 (emergency medical services environment).
• Plan and manage mechanical safety testing to IEC 60601-1, including mechanical strength, shock and vibration, drop, impact, and mold-stress-relief and enclosure integrity testing for handheld and portable equipment.
• Own radio and wireless regulatory testing and certification, including FCC (US), ISED/IC (Canada), and CE/RED (EU), coordinating with notified bodies and accredited test labs.
• In collaboration with the QA/RA team, develop and maintain risk management documentation in accordance with ISO 14971, including risk management plans, hazard analyses, risk assessments, and risk management reports. · In collaboration with the QA/RA team, develop and maintain usability engineering documentation in accordance with IEC 60601-1-6 and IEC 62366-1, including use specifications, use-related risk analyses, and formative and summative evaluation reports.
• In collaboration with the QA/RA team, develop and maintain technical aspects of device user manual.
• Coordinate biocompatibility evaluation of patient-contacting materials in accordance with ISO 10993, including preparation of biological evaluation plans/reports and liaison with test laboratories on material and cytotoxicity testing.
• Author and review test plans, protocols, reports to ensure alignment with applicable standards and internal design control requirements.
• Support regulatory submissions (FDA, Health Canada, EU MDR, and other markets) by providing compliance evidence, test data, and technical documentation.
• Perform pre-compliance measurements and design reviews, and work with hardware, firmware, and mechanical teams to identify and resolve compliance issues early in the design cycle.
• Maintain awareness of evolving standards and regulatory requirements and assess their impact on current and future products.
• Interface with external test laboratories, certification bodies, and notified bodies to schedule, execute, and close out testing and certification activities.
• Comply with the company's Quality Management System (ISO 13485) and applicable project plans and industry standards

Your Experience So Far:

• Bachelor's or master's degree in electrical engineering, electronics engineering, mechatronic engineering, or related discipline.
• Minimum 3 years of experience in hardware compliance, EMC, or product safety engineering, preferably in the medical device industry.
• In-depth knowledge of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-1-12.
• Knowledge of the mechanical safety requirements of IEC 60601-1 (mechanical strength, shock, vibration, drop, and impact testing) for handheld and portable devices.
• Hands-on experience planning and executing EMC testing (emissions and immunity) and interpreting results against applicable limits.
• Experience with wireless/radio regulatory certification, including FCC, ISED/IC, and CE/RED requirements.
• Working knowledge of risk management (ISO 14971) and usability engineering (IEC 60601-1-6 and IEC 62366-1) processes and documentation.
• Familiarity with biocompatibility material testing and evaluation to ISO 10993 for patient-contacting components.
• Familiarity with the medical device software lifecycle (IEC 62304) and quality management systems (ISO 13485).
• Experience liaising with accredited test laboratories, certification bodies, and notified bodies.
• Ability to read and interpret circuit schematics and PCB layouts to support pre-compliance analysis.
• Proficiency with EMC and safety test equipment (spectrum analyzers, EMI receivers, LISNs, hipot/leakage testers, oscilloscopes).
• Strong interpersonal skills and verbal and written communication skills in English.
• Attention to detail and the ability to produce clear, well-organized technical documentation

Location and Compensation:

This is a hybrid/remote role, therefore we can only consider candidates who are based within a commutable distance from our Vancouver, BC office. The salary range for this role is set at ()()

Location and Compensation:

This is a remote role, open to candidates across Canada. The salary range for this role is set at ()()

More Reasons to Consider:

Be Part of a High-Impact Project – You'll play a key role in creating a more affordable ultrasound solution, making medical imaging more accessible worldwide.

Work for a Three-Time Certified Great Place to Work – Clarius has been recognized three times as a great place to work, and you'll be joining a company that values innovation, teamwork, and employee well-being.

Workspace: Our modern office features sit/stand desks, various health & wellness facilities, a stocked kitchen, outdoor amenities, on-site daycare, enclosed parking, a free on-site gym and close proximity to a SkyTrain station.

Clarius Mobile Health is proud to be an Equal Opportunity Employer. We encourage applications from any qualified candidate regardless of ethnicity, religion, age, national origin, disability status, sexual orientation, gender identity or expression. Please let us know if you require any accommodations during the interview process.

Use of Artificial Intelligence in the Recruitment Process

As part of our recruitment and assessment process, we may use artificial intelligence tools to support certain activities. This may include, but is not limited to, reviewing applications, supporting candidate assessments, and conducting or facilitating one way video interviews.

Where AI tools are used, they are intended to support our recruitment process and do not replace human decision making. Candidates may be informed where AI is used as part of an assessment and will have the opportunity to engage with the recruitment process in accordance with applicable laws and our recruitment practices.

• achelor's or master's degree in electrical engineering, electronics engineering, mechatronic engineering, or related discipline.
• Minimum 3 years of experience in hardware compliance, EMC, or product safety engineering, preferably in the medical device industry.
• In-depth knowledge of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-1-12.
• Knowledge of the mechanical safety requirements of IEC 60601-1 (mechanical strength, shock, vibration, drop, and impact testing) for handheld and portable devices.
• Hands-on experience planning and executing EMC testing (emissions and immunity) and interpreting results against applicable limits.
• Experience with wireless/radio regulatory certification, including FCC, ISED/IC, and CE/RED requirements.
• Working knowledge of risk management (ISO 14971) and usability engineering (IEC 60601-1-6 and IEC 62366-1) processes and documentation.
• Familiarity with biocompatibility material testing and evaluation to ISO 10993 for patient-contacting components.
• Familiarity with the medical device software lifecycle (IEC 62304) and quality management systems (ISO 13485).
• Experience liaising with accredited test laboratories, certification bodies, and notified bodies.
• Ability to read and interpret circuit schematics and PCB layouts to support pre-compliance analysis.
• Proficiency with EMC and safety test equipment (spectrum analyzers, EMI receivers, LISNs, hipot/leakage testers, oscilloscopes).
• Strong interpersonal skills and verbal and written communication skills in English.
• Attention to detail and the ability to produce clear, well-organized technical documentation