Brief description of the position :
In order to meet the needs of our customers in the Medical Devices sectors, FOP CONSULTANTS is looking for research and development consultants motivated to carry out mandates. The main missions would be to manage R&D projects for medical products and devices, improve existing products and develop new products, ensure compliance with regulatory requirements, identify opportunities for developing new products, write all the documentation necessary for the development of medical devices and collaborate on any project related to biomedical engineering.
Main responsibilities :
Without limitation, the main tasks involve:
- Manage R&D projects on the improvement and development of medical devices;
- Assist the marketing team in the analysis of medical device market needs (positioning, differentiation, range extension) of the client's product portfolio;
- Act as an expert by providing technical and scientific support to clients;
- Participate in the development of new products and the improvement of existing products;
- Ensure compliance with standards and regulatory requirements in the development process;
- Define and maintain product specifications required for quality control testing;
- Monitor development projects internally and externally and ensure that deadlines are met;
- Write all documentation (SOPs, etc.) involved in product development;
- Perform risk analyzes related to products and during the launch of new products;
- Provide solutions to problems encountered and perform all tasks relevant to the mandate.
Qualifications :
- Bachelor's or master’s degree in engineering (biomedical; biomechanics, mechanics, physics) or other related discipline;
- 1 (one) to 10 (ten) years of experience in the medical device, hospital or related industry;
- Project management (an asset);
- Experience in product development and R&D of medical devices;
- Knowledge of ISO 13485 standard;
- Knowledge of FDA, Health Canada regulations;
- Knowledge of classes I, IIa, IIb and III of medical devices;
- Excellent command of MS Office suite;
- Good communication and writing skills in French and English;
- Mobility (an asset).
Personal skills :
- Leadership;
- Rigor et discipline;
- (Organize), able to manage several projects;
- Analytical and critical mindset;
- Perseverance;
- Humility.
What we offer :
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:
- Competitive wages;
- Group insurance;
- Professional insurance;
- Remote work, according to the customer needs;
- Vacations: 3 weeks;
- Paid sick leave: 3 days;
- Monthly transportation fees;
- Career advancement opportunity;
- Continuing education.
