Engineer/Project Manager, biomedical

Brief description of the position :

In order to meet the needs of our customers in the Medical Devices sectors, FOP CONSULTANTS is looking for biomedical engineering consultants to carry out various mandates. The main missions would be to manage projects related to biomedical engineering, collaborate during purchasing, commissioning and biomedical equipment maintenance, design installation layouts, proceed to risks analysis of the biomedical equipment operational processes, participate to lean management programs, ensure regulation and health and safety requirements conformity, write the standard operating procedures and collaborate on any project related to biomedical engineering.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage purchasing, commissioning and lean management on projects related to the biomedical engineering;
• Analyze requirements, design specifications and bid for equipment;
• Maintain the PCEM updated and evaluate existing medical equipment’s reliability;
• Design medical equipment ‘s organization layout;
• Ensure health and safety rules’ respect in operational areas;
• Write standard operating procedures (SOP) related to the biomedical engineering;
• Train or participate to the training of the biomedical engineering department;
• Participate to lean management and R&D programs, and proceed to technology intelligence;
• Perform audits in order to identify gaps and then implementing remediation plans;
• 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 any 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 biomedical engineering (an asset);
• 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.