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Biomedical Engineers (Sr.)

FOP Experts Conseils inc.

202-9420 Boulevard Taschereau, Brossard,QC

Salary To be discussed
37.50 to 40.0 h - Full time
Contract ,Permanent ,Telecommuting job
Day shift work
Published since 5 day(s)
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3 positions to fill as soon as possible

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Benefits

Commitment to work-life balance
Disability insurance
Floating leave days
Insurance
On-going training
Paid leave
Paid sick leave
Performance bonuses
Reimbursement for public transportation

Description

POSITION DESCRIPTION

FOP CONSULTANTS is looking for Biomedical Engineers at the senior 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. The senior scope is further to define the technical architecture of devices and arbitrate design choices and to mentor intermediate consultants and review their deliverables.

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.
Define the technical architecture of devices and arbitrate design choices.
Mentor intermediate consultants and review their deliverables.
Support submission files with the authorities.

CANDIDATE PROFILE

Bachelor's or master's degree in engineering (biomedical; biomechanics, mechanics, physics) or any other related discipline.
Minimum ten (10) years of industry experience.
Eight (08) to fifteen (15) 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 environment 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;
Professional 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 opportunities for advancement within the organization;
Ongoing access to training to grow your skills.

Equal Opportunity Employer

This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.

Requirements

Level of education

University

Diploma

BAC

Completed

Work experience (years)

10+ years

Written languages

Fr : Advanced

En : Intermediate

Spoken languages

Fr : Advanced

En : Intermediate

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