POSITION DESCRIPTION

FOP CONSULTANTS is looking for Biomedical Engineers at the intermediate level motivated to deliver on mandates for its clients in the medical device sector. The mandate is to design and improve medical devices in accordance with design controls and to manage risks (ISO 14971), support testing (IEC 60601) and document the DHF in compliance with ISO 13485 and FDA and Health Canada requirements.

KEY RESPONSIBILITIES
Design and improve medical devices in accordance with design controls.
Define design input requirements and technical specifications.
Perform risk management in accordance with ISO 14971.
Support electrical safety and performance testing (IEC 60601).
Build and maintain the design history file (DHF) and the technical file.
Collaborate with R&D;, quality, manufacturing and regulatory affairs.
Ensure compliance with ISO 13485, FDA 21 CFR 820 and the Medical Devices Regulations.

CANDIDATE PROFILE
Bachelor's or master's degree in engineering (biomedical; biomechanics, mechanics, physics) or any other related discipline.
Five (05) to ten (10) years of industry experience.
Three (03) to seven (07) years of experience as a Biomedical Engineer.
Sector standards: ISO 13485, ISO 14971, FDA 21 CFR 820,



EU MDR 2017/745, MDSAP.
Tools and systems: MS Office suite, SolidWorks, MATLAB, Minitab, MS Project.
Hold one of the following certifications: ISO 14971, ISO 13485.
The following are considered assets: membership in the Ordre des ingénieurs du Québec (OIQ), PMP, ASQ CQE, Six Sigma Green Belt.
Experience in Canadian public or private organizations.
Language: French and English

WORK MODE
Remote, Hybrid, On-site

WHAT WE OFFER

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an setting designed to support your performance and respect your work-life balance, including:
Competitive compensation that reflects your expertise;
Complete protection through our group insurance plans;
Skilled liability insurance so you can practise with confidence;
Remote-work flexibility, based on client needs;
3 weeks of vacation to recharge;
3 paid sick days, to take care of yourself;
A monthly allowance for your transportation costs;
Real prospects for advancement within the organization;
Ongoing access to training to grow your skills.

📌 Biomedical Engineers Int Brossard
🏢 FOP Experts Conseils
📍 Brossard