POSITION DESCRIPTION

FOP CONSULTANTS is looking for Research and Development Engineers at the senior level motivated to deliver on mandates for its clients in the medical device sector. The mandate is to design and develop creative medical devices, from prototype to manufacturing transfer and to apply design controls and risk management, assess biocompatibility and document designs in compliance with ISO 13485. The senior scope is further to define the product research and development roadmap and to mentor intermediate consultants and review their deliverables.

KEY RESPONSIBILITIES

- Design and develop new medical devices and their improvements.
- Carry out proofs of concept, prototypes and preliminary testing.
- Apply design controls and risk management (ISO 14971).
- Select materials and assess biocompatibility (ISO 10993).
- Draft specifications, technical reports and design documentation.
- Transfer designs to manufacturing.
- Collaborate with clinicians, quality and regulatory affairs.
- Define the product research and development roadmap.
- Mentor intermediate consultants and review their deliverables.
- Advise management on the innovation portfolio

CANDIDATE PROFILE

- Bachelor's or master’s degree in engineering (biomedical; biomechanics, mechanics, physics) or other related discipline.
- Minimum ten (10) years of industry experience.
- Eight (08) to fifteen (15)



years of experience as a Research and Development Engineer.
- Sector standards: ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR 2017/745, MDSAP.
- Tools and systems: MS Office suite, SolidWorks, Minitab, JMP, MS Project.
- Hold one of the following certifications: Six Sigma Green Belt, Design of Experiments (DOE).
- The following are considered assets: membership in the Ordre des ingénieurs du Québec (OIQ), PMP, ASQ CQE, intellectual property training.
- 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.

📌 Research and Development Engineers (Sr.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City