Remote Compliance Engineer — Medical Device Hardware & Regulatory

Clarius Mobile Health; Vancouver; Hybrid; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Great Place to Work certification

Hybrid work model

Job summary

Clarius Mobile Health seeks an experienced hardware compliance engineer to lead EMC, electrical and mechanical testing for handheld ultrasound devices. You will coordinate with labs, manage regulatory submissions (FDA/Health Canada/EU MDR) and own risk management documentation with QA/RA teams.

You will influence design reviews, ensure ISO 13485 alignment, and drive pre-compliance activities across electrical, mechanical and radio domains with a hands-on and orchestrating approach.

Qualifications

• Bachelor's or master's degree in electrical engineering, electronics engineering, mechatronic engineering, or related discipline.
• Minimum 3 years of hardware compliance, EMC, or product safety engineering, preferably in medical devices.
• Knowledge of IEC 60601 family and regulatory standards as listed.

Responsibilities

• Plan, coordinate, and manage EMC and electrical safety testing to IEC 60601 series.
• Coordinate regulatory submissions and liaise with laboratories and notified bodies.
• Develop risk management and usability documentation with QA/RA teams.
• Maintain device manuals and documentation for compliance across markets.

Skills

IEC 60601-1

IEC 60601-1-2

IEC 60601-1-11

IEC 60601-1-12

EMC testing

Electrical safety testing

Mechanical safety testing

FCC/ISED/CE regulatory

ISO 14971

IEC 60601-1-6

IEC 62366-1

ISO 10993

IEC 62304

ISO 13485

Reading schemas/PCB layouts

Pre-compliance analysis

Education

Bachelor's or Master's in electrical/electronics/mechatronic engineering

Tools

Spectrum analyzers

EMI receivers

LISNs

Hipot testers

Oscilloscopes

Job description

Clarius Mobile Health seeks an experienced hardware compliance engineer to lead EMC, electrical and mechanical testing for handheld ultrasound devices. You will coordinate with labs, manage regulatory submissions (FDA/Health Canada/EU MDR) and own risk management documentation with QA/RA teams.

You will influence design reviews, ensure ISO 13485 alignment, and drive pre-compliance activities across electrical, mechanical and radio domains with a hands-on and orchestrating approach.