Sr. Test Engineer Burnaby Canada – Immigration Support Possible

Visa type confirmed: Immigration Support Possible

Job Overview

Our client is seeking a qualified candidate for a role involving the management and completion of activities related to Design Verification (DV) for multiple New Product Development (NPD) programs. Immigration support may be available for the right candidate.

Responsibilities

• Manage and complete DV activities for multiple NPD programs.
• Develop DV project plan based on program scope, including deliverables, timelines, and resource needs.
• Identify, ideate, and oversee development of novel engineering test methods and fixtures for DV.
• Identify and oversee development of verification plans, protocols, and reports.
• Peer-review and provide feedback on team deliverables for technical soundness and audit-readiness.
• Oversee technical and schedule communication with internal and external partners to manage and retire risks efficiently.
• Collaborate with test engineers, design engineers, and cross-functional teams to analyze product test failures and recommend solutions.
• Provide critical updates to management including Test and Design Engineering Managers.
• Develop and maintain subject matter expertise in applicable technical standards for medical device development e.g., ISO 10993, ISO 8600, and IEC 60601-1.
• Identify and implement improvements to the verification test system via e.g., standardization, tools, and automation.
• Ensure deliverables comply with applicable regulatory standards e.g., ISO 13485, 21 CFR part 820, and 21 CFR Part 11.
• Follow our client’s Quality Management System and documentation practices.
• Ensure completion of tasks within project schedule and with high attention to detail.

Qualifications

• Bachelor’s degree in engineering (mechanical, mechatronics, or similar); Advanced degree preferred.
• P.Eng from the EGBC preferred; ability and willingness to obtain a P.Eng license required.
• 8+ years of test/design/systems engineering experience in a product development environment, some of which is within medical device R&D.
• Strong analytical foundation, using engineering principles for problem-solving during NPD.
• Hands-on experience developing and qualifying engineering test methods & tools.
• Hands-on experience with developing electromechanical systems and root cause analysis.
• Experience managing and delivering design verification in a highly regulated industry.
• Experience using project planning tools and concepts.
• Experience using statistical techniques, preferably using Minitab.
• Proficient in writing concisely and accurately with meticulous attention to detail and clarity.
• Strong verbal and written communication skills, suited for a cross-functional environment.
• Ability to work within tight deadlines with transparent communication.
• Familiar with CAD tools and microcontrollers (e.g. Arduino); hands-on experience preferred.
• Familiar with medical device applicable technical and regulatory standards e.g., ISO 10993, ISO 8600, and IEC 60601-1, 21 CFR Part 11; hands-on experience preferred.
• Experience with Jama (for requirements management) and Jira (for issue tracking) preferred.

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