Sr, Test Engineer - Medical Device R&D - $120K - $130k +

OpTalent | Recruitment; Burnaby; On-site; CAD 120,000 - 130,000; Full time

Job summary

An established industry player is seeking a Senior Test Engineer to lead Design Verification activities for innovative medical devices. This role involves developing project plans, overseeing engineering test methods, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in test engineering, strong analytical skills, and a commitment to quality. Join a dynamic team dedicated to advancing medical technology and improving patient outcomes. If you are passionate about engineering and eager to make a significant impact, this opportunity is perfect for you.

Qualifications

• 8+ years in test/design/systems engineering, including medical device R&D.
• Hands-on experience developing engineering test methods and tools.

Responsibilities

• Manage Design Verification activities for New Product Development programs.
• Collaborate with teams to analyze product test failures and recommend solutions.

Skills

Analytical Skills

Problem-Solving

Communication Skills

Attention to Detail

Education

Bachelor’s degree in engineering

P.Eng from EGBC

Tools

Minitab

CAD tools

Jama

Jira

Job description

Senior Test Engineer - Medical Device R&D - $120K - $130K+

Manage and complete Design Verification (DV) activities for multiple New Product Development (NPD) programs.

1. Develop DV project plans based on program scope, including deliverables, timelines, and resource needs.
2. Identify, ideate, and oversee development of novel engineering test methods and fixtures for DV.
3. Develop verification plans, protocols, and reports, and peer-review team deliverables for technical soundness and audit readiness.
4. Oversee communication with internal and external partners to manage and retire risks efficiently.
5. Collaborate with test engineers, design engineers, and cross-functional teams to analyze product test failures and recommend solutions.
6. Provide critical updates to management, including Test and Design Engineering Managers.
7. Develop and maintain expertise in applicable technical standards such as ISO 10993, ISO 8600, and IEC 60601-1.
8. Identify and implement improvements to the verification test system via standardization, tools, and automation.
9. Ensure deliverables comply with regulatory standards like ISO 13485, 21 CFR part 820, and 21 CFR Part 11.
10. Follow company’s Quality Management System and documentation practices.
11. Ensure completion of tasks within project schedules with high attention to detail.

Qualifications

• Bachelor’s degree in engineering (mechanical, mechatronics, or similar); advanced degree preferred.
• P.Eng from EGBC preferred; ability and willingness to obtain a P.Eng license required.
• 8+ years of experience in test/design/systems engineering, including medical device R&D.
• Strong analytical skills using engineering principles for problem-solving during NPD.
• Hands-on experience developing and qualifying engineering test methods and tools.
• Experience with electromechanical systems and root cause analysis.
• Experience managing and delivering design verification in a regulated industry.
• Proficiency with project planning tools and statistical techniques (preferably Minitab).
• Excellent written and verbal communication skills, meticulous attention to detail.
• Familiarity with CAD tools, microcontrollers (e.g., Arduino), and relevant standards (ISO 10993, ISO 8600, IEC 60601-1, 21 CFR Part 11).
• Experience with Jama and Jira is preferred.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Industry: Manufacturing