Senior Process Quality Engineer (Hybrid)

at  Kardium Inc

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.
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.
Meaningful work you will be a part of

As a Senior Quality Engineer, you will be an integral part of ensuring that Kardium is consistently producing high-quality medical devices that change the lives of patients. Your core responsibilities will include:

• 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.
• The opportunity to mentor junior members of the QE team, making the most of your knowledge & experience to help cultivate a high-performing environment.

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 are suited to our approach and possess these attributes and abilities:

• Bachelor’s degree or higher in science or engineering.
• At least 7 years of quality engineering experience in a technical, multi-disciplinary environment.
• Experience with medical devices or similarly regulated industries is advantageous.
• 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.
• Demonstrated leadership skills and ability to drive results in a timely manner.
• Driven, motivated, curious, and able to work both independently and as part of a team.

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.

• $93,000 – 127,000 (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

• 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.
• The opportunity to mentor junior members of the QE team, making the most of your knowledge & experience to help cultivate a high-performing environment