Process Quality Engineering Team Lead - Operations; Hybrid

Position: Process Quality Engineering Team Lead - Operations (Hybrid)
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 diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.

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 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 have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch.

This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients. As a Process Quality Engineering Team Lead – Operations, you will lead the investigation and resolution of quality issues within the Catheter/Introducer sub assembly processes, with a strong focus on non-conformance (NC) disposition and rework activities. You will manage a team of Process Quality Engineers and act as the primary point of contact for production quality concerns across a two-shift operation.

Meaningful work you will be a part of
Your Responsibilities Will Be To

Develop a detailed understanding of Kardium’s products and their manufacturing processes, then apply that knowledge proactively across the areas described below

Lead a team of Process Quality Engineers in a fast-paced manufacturing environment, triage, prioritize and schedule both operational and project work

Lead the investigation in collaboration with engineering subject matter experts, review, and disposition of non-conforming products and materials

Support and drive continuous improvement initiatives, including investigations into systemic product quality issues

Build and maintain strong cross-functional partnerships with Quality Control, Engineering, Manufacturing, and Quality Assurance

Design, implement, and continuously improve processes for monitoring, evaluating, and reporting on product quality trends and process performance

What You Bring To The Team
Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You will be successful in this role because you possess these attributes:

Bachelor’s degree or higher in science or engineering; a mechanical engineering background is preferred

At least 8 years of engineering experience in a technical, multi-disciplinary environment; experience with medical devices or similarly regulated industries is highly advantageous

Excellent interpersonal skills, with a track‑record of driving consensus with diverse stakeholders

Excellent written and verbal communication skills, especially in a technical context

Proven experience with non-conformances, failure investigations, root-cause analysis, and other tools typically applied by quality engineers

A sound knowledge of statistics and concepts such as SPC, FMEA, process capability, etc.

Compensation
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