Verification and Validation Engineer

Job Description

Verification and Validation Engineer

• Full-time, permanent position
• Pay Rate : $85k to $95k base + bonus + benefits
• On-site North York, Ontario

We at Raise are hiring for one of our key clients in the medical device industry. After establishing themselves as an industry leader, our client’s team is expanding to meet rising demand.

They’re looking for skilled technical professionals like you to help complete meaningful and impactful projects specifically for a device that is not available commercially anywhere else in the world.

Our client takes pride in their people. When you join their team, you’ll find a workplace that facilitates challenge, achievement, and growth.

Responsibilities :

• Collaborate across functions (e.g. R&D engineering and Quality) to understand and input on system design requirements as the Subject Matter Expert (SME)
• Document the Design Verification (DV) plan to ensure traceability to all requirements including risk items, hazards, and Failure Modes and Effects Analysis (FMEA)
• Develop system verification and validation test protocols, plans, and cases in consultation with R&D engineering ensuring alignment with schedules and utilizing a risk-based approach
• Co-ordinate design verification configurations under test while managing and / or qualifying required equipment and fixtures
• Execute and / or co-ordinate system verification activities including testing
• Document internal or third-party testing results
• Analyse internally produced and / or third-party test results for the purposes of identifying root cause of failures and / or opportunities for design improvements where applicable
• Report verification and validation test results and analysis to R&D team including as part of design review meetings
• Support the transfer of product to manufacturing
• Align with Quality and Regulatory functions to ensure verification and validation activities are compliant with quality procedures, standards, and guidelines (e.

g. sample sizes, evaluation types, usability inputs)

• Contribute to reviews and improvements in the verification and validation process
• Participate in, and adhere to, health and safety initiatives and requirements

Qualifications :

• Post-secondary education ideally in engineering preferably in areas such as mechanical, electrical, mechatronics, or biomedical
• Experience in system verification and validation from requirements to regulatory submission ideally in the medical device industry
• Proficient in design testing to functional requirements, system integration testing to product requirements, reliability testing, usability testing, as well as regression analysis / testing for design changes
• Awareness and understanding of quality standards such as ISO ideally 13485
• Knowledge and skills in statistical process measurement and data analysis
• Experience with Design of Experiment (DOE)
• Proficient in Microsoft Office applications such as Word, Excel, Outlook, Project, and Access
• Competencies include teamwork, attention to detail, analytical, time management, as well as clear and concise verbal and written communication skills
30+ days ago