Engineer/Specialist, verification & validation.

Brief description of the position :

In order to meet the needs of our customers in the Medical Devices sectors, FOP CONSULTANTS is looking for V&V engineer consultants to carry out various mandates. The main missions would be to manage projects related to designing and verifying medical device specifications, coordinate and validate R&D efforts, ensure profitability of the medical device in development, write procedures, and collaborate on any other project related to biomedical engineering.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage projects in medical device designing and validating;
• Elaborate specifications folder for new medical device and review existing ones;
• Collaborate with R&D departments to elaborate specifications;
• Identify bugs and coordinate their resolution by collaborating with developers’ teams;
• Verify and validate the specifications meet the established requirements;
• Use risks analysis tools (FMEA, etc.) to make product risks analysis;
• Proceed to profitability studies by collaborating with marketing and R&D departments to ensure developed medical device’s return on investment;
• Participate to weekly or monthly meetings regarding the progress of the projects;
• 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 verification and validation as well as equipment design and specification writing (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.