Mechanical Testing Team Lead

2 weeks ago

Burnaby, Canada Kardium Full time

Application Deadline: May 31st, 2024

**Your opportunity**

By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the mínimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

Our testing team at Kardium is looking for a star leader to support ongoing verification and validation activities leading up to the commercialization of our medical device and beyond. The main focus of the Mechanical Testing Team Lead is to ensure that the mechanical testing team can objectively verify and test Kardium's products and designs. Testing of high-complexity medical devices is a key component for Kardium as it transitions to simultaneously supporting commercial manufacturing, supporting ongoing product improvements, and supporting future product designs.

Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

**What you'll be doing**

Your responsibilities will include:
**Planning and execution of all mechanical design verification and process validation activities**
- Plan the scope of mechanical testing, ensuring coverage of essential requirements, external standards, and effectiveness of risk mitigations.
- Participate in design and process requirement reviews to ensure that requirements can be validated and verified.
- Assess and plan ECO, change-control-related, and other QMS-related verification activities related to mechanical design or process changes.
- Drive mechanical design verification reviews.
- Ensure adequate test articles are available for testing, including planning type and quantity, requesting sample production, assisting sample release, and organizing required preconditioning.
- Prioritize, schedule, track, and conduct mechanical V&V activities in coordination with stakeholders.
- Drive generation and maintenance of V&V documentation, including TPs, TRs, design verification reviews, detailed test and sample planning and tracking documents, traceability upkeep and matrices, as well as high‐level planning documents and high‐level reports to support regulatory submissions.
- Coordinate with TLs and requirement document owners to ensure that conclusions of test reports and design review reports are adequately acted upon.

**D**evelopment and maintenance of a company‐wide support infrastructure for testing**
- Test equipment, jigs, and fixtures:

- Identify and document requirements.
- Drive design (where applicable), procurement, and implementation, as well as commissioning and qualification.
- Ensure all equipment used in testing is calibrated and maintained as required.
- Build in‐house knowledge on sampling plans, statistics relating to test result analysis, and experimental design. Provide testing and analysis support to all groups within Kardium.
- Identify, document, and validate Standard Test Methods and Test Method Validations.
- Coordinate with Engineering TLs to set up and manage mechanical testing lab space.
- Maintain the mechanical V&V related SOPs, plans, and procedures.
- Improve the documentation and organization of mechanical V&V activities to enable better scaling and test result tracking.
- Ensure test personnel training and domain knowledge is up to date, current, and state of the art.

**Team Leadership**
- Ensure adequate staffing level for mechanical V&V activities based on work scope and required areas and levels of expertise.
- Provide constant feedback to team members and conduct performance and compensation reviews.
- Provide mentorship to junior team members.
- Work with team members to identify and address training needs.

**What you bring to the team**

**Experience and Qualifications**:

- Bachelor of Science or Engineering degree.
- Minimum of 5 years of experience in design or test engineering.
- Multidisciplinary understanding of medical device system.

**Skills and Attributes**:

- Solid communication and documentation skills.
- Flexible and adaptable to take on additional responsibilities as appropriate
- Familiarity with international standards and FDA guidance documents related to medical devices, especially as they relate to V&V; (e.g.ISO 14971, CFR 21 Part 820, IEC 60601, ISO 17025, ISO 10555)
- Strong organizational, leadership, and management skills.

**Compensation**
- $102,000 - 120,000 (CAD Annually)

**Why work at Kardium**

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

- Knowing every day that you are making a

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