Process Quality Engineer - Mechanical (Hybrid)

Kardium Inc.Burnaby, BC
Hybrid

About The Position

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 diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications. Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story. We are now preparing for our upcoming commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients. In this role, you will be joining Kardium’s Quality Engineering team and working to support the manufacture of a complex class III medical device. This is an exciting time for the team, as our efforts are closely tied to Kardium’s ambitious goals for scaling production capacity with our commercial launch. Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

Requirements

  • Bachelor’s degree or higher in science or engineering.
  • 0-3 years of engineering experience in a technical, multi-disciplinary environment.
  • Proven experience with failure investigations, root-cause analysis, non-conformances, and other tools typically applied by quality engineers.
  • A sound knowledge of statistics and concepts such as SPC, FMEA, process capability, etc.
  • Excellent written and verbal communication skills, especially in a technical context.
  • Strong interpersonal skills, with a demonstrated ability to build relationships in the workplace and interface effectively across varying teams and levels of the business.
  • Driven, motivated, curious, and able to work both independently and as part of a team.

Nice To Haves

  • Experience with medical devices or similarly regulated industries is highly preferred.

Responsibilities

  • Developing a detailed understanding of Kardium’s products and their manufacturing processes, then applying that knowledge proactively across the areas described below.
  • Driving the investigation, review, and disposition of non-conforming products and materials.
  • Leading detailed technical investigations, root-cause analyses, and benchtop testing, in collaboration with engineering subject matter experts, to solve quality issues and provide corrective or preventative actions.
  • Developing processes for monitoring, evaluating, and reporting on product quality and process stability, adjacent to the development of Kardium’s maturing ERP system.
  • Identifying process & operational trends and collaborating with internal teams to champion solutions for corrections or improvements.
  • Managing longer-term projects that contribute towards Continuous Improvement goals and the creation of a world-class manufacturing environment at Kardium.

Benefits

  • Total cash compensation range (base salary + 5% RRSP contribution)
  • Stock option plan
  • Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period.
  • 3 personal days per year.
  • Support for well-being (for employees and dependents).
  • Career progression and learning support.
  • Professional membership support.
  • Top up for maternity leave & adoptive leave.
  • Benefit coverage for fertility drug treatment.
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