Mechanical Testing Team Lead (Hybrid)

Kardium Inc.; Burnaby; Hybrid; CAD 105,000 - 120,000; Full time

Job summary

An innovative company is seeking a Mechanical Testing Team Lead to play a crucial role in ensuring the quality and effectiveness of groundbreaking medical devices. This position involves overseeing mechanical testing processes, managing a skilled team, and collaborating on product development efforts. The ideal candidate will have a strong engineering background and experience in design verification, ensuring compliance with international standards. Join a passionate team dedicated to improving patient outcomes and advancing medical technology in a supportive and flexible work environment.

Benefits

Comprehensive medical and dental coverage

Flexible work arrangements

Personal days

Support for career growth

Stock options

Top-ups for maternity and adoptive leaves

Support for fertility treatments

Qualifications

• 5+ years of experience in design or test engineering.
• Understanding of international standards related to V&V.
• Strong communication and documentation skills.

Responsibilities

• Plan and execute mechanical design verification activities.
• Manage change-control verification activities.
• Schedule and conduct V&V activities, coordinating with stakeholders.

Skills

Design Engineering

Test Engineering

Communication Skills

Organizational Skills

Leadership Skills

Knowledge of FDA Standards

Education

Bachelor's degree in Science or Engineering

Tools

Testing Equipment

Job description

Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada Req #308

May 6, 2025

Your opportunity :

Join the Kardium team and contribute to making a difference in the lives of millions worldwide. We have developed a groundbreaking medical device for diagnosing and treating atrial fibrillation, a common heart rhythm disorder that can lead to stroke, heart failure, and other complications.

Kardium’s mission is to provide the best treatment for atrial fibrillation. We have created The Globe Pulsed Field System, supported by a skilled technical team that developed a product with strong, unique differentiators in the market. We have established connections with key opinion leaders who are actively using the Globe System and helping to share our story.

Having completed our pivotal clinical study, we are now focusing on obtaining regulatory approvals and launching commercially. This milestone marks a significant step toward bringing this innovative technology to patients.

Position Overview:

The Mechanical Testing Team Lead will ensure that testing resources effectively verify and validate Kardium’s products and designs. Mechanical testing of high-complexity medical devices is crucial for product development, quality assurance, and competitiveness. The scope of testing for the Globe system is extensive and vital for our success.

This role offers a hybrid work arrangement, based in Burnaby, BC.

Meaningful work you will be a part of

Your responsibilities include:

1. Planning and executing mechanical design verification and process validation activities.
2. Defining testing scope, ensuring compliance with requirements, standards, and risk mitigations.
3. Participating in design reviews to ensure requirements can be validated and verified.
4. Managing change-control verification activities related to mechanical design or process changes.
5. Ensuring availability of test articles, organizing sample production, and preconditioning.
6. Scheduling, prioritizing, and conducting V&V activities, coordinating with stakeholders.
7. Maintaining V&V documentation, including test plans, reports, and traceability matrices.
8. Handling issues and CAPAs related to mechanical verification and validation.
9. Coordinating with other teams to ensure proper actions on test report conclusions.

Development and maintenance of testing infrastructure:

1. Identifying requirements for test equipment, jigs, and fixtures.
2. Driving design, procurement, and qualification of test equipment.
3. Ensuring calibration and maintenance of testing equipment.
4. Building expertise in sampling, statistics, and experimental design; providing support across teams.
5. Standardizing test methods and validation processes.
6. Setting up and managing the mechanical testing lab.
7. Maintaining SOPs, plans, and procedures related to V&V activities.
8. Improving documentation and organization for scalability and tracking.
9. Training test personnel and maintaining their expertise.
10. Ensuring adequate staffing for V&V activities.
11. Providing feedback, conducting performance reviews, and mentoring team members.
12. Collaborating to identify and address training needs.
13. Creating a vision for the Testing Team to support scalable product development.

Qualifications:

Our team is innovative, collaborative, and passionate about advancing medical technology. To succeed in this role, you should have:

• Bachelor’s degree in Science or Engineering.
• At least 5 years of experience in design or test engineering.
• Multidisciplinary understanding of the Globe system.
• Strong communication and documentation skills.
• Flexibility and adaptability for additional responsibilities.
• Knowledge of international standards and FDA guidance related to V&V, such as ISO 14971, IEC 60601, ISO 10555, CFR 21 Part 820.
• Excellent organizational, leadership, and management skills.

Compensation and Benefits:

We offer a total cash compensation range of $105,000 - $120,000 CAD annually, including base salary and a 5% RRSP contribution. Additionally, employees are eligible for stock options, comprehensive medical and dental coverage from day one, flexible work arrangements, personal days, and support for well-being, career growth, and family building. We also support professional memberships and provide top-ups for maternity and adoptive leaves, including fertility treatments.

Life at Kardium

What makes us a great place to work?

• Our Purpose
• Our People
• Our Culture

We value diversity and inclusion, actively supporting Employee Resource Groups such as Women ERG, Pride ERG, REACH, and others. We encourage applicants to specify if they require accommodations during the recruitment process. Learn more about us on Glassdoor!

Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, BC, Canada