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.
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
Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.
As a permanent employee, you will also participate in Kardium’s stock option plan.
• $102,000 – $146,000 (CAD Annually)
Your Benefits & Well-being
Total cash – the total cash we’ve listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.
Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period.
Work-day flexibility – additionally, we provide 3 personal days per year.
Support – for you (and your dependents) overall well-being.
Career progression and learning support.
Professional membership support.
Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
Life at Kardium
What makes us a great place to work?
1. Our Purpose
2. Our People
3. Our Culture
At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.
We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Brazilian ERG and Irish ERG.
As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.
And our employees think we are great too – check out Glassdoor to learn more!