Systems 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 the Systems Engineering – Implementation team, and collaborate with colleagues in Engineering, Testing, Regulatory Affairs, Risk Management and Clinical Engineering teams.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of

As a Systems Engineer, you will be an integral part of our multidisciplinary engineering team, working across the mechanical, regulatory, usability, and risk management domains. Your daily activities will center around supporting requirements management and product design and development. Your core responsibilities will include:

• Managing product design requirements, and communicating those with risk management, regulatory affairs, design, and test engineering teams
• Ensuring design controls are appropriately applied and documented during product development
• Supporting the risk management process by developing requirements that mitigate system risks
• Investigating issues identified during verification and clinical use of the device, and as a subject matter expert, driving resolution with interdisciplinary teams
• Becoming familiar with and staying current on relevant medical device standards and regulations

The Systems Engineering team is flexible and affords the opportunity to work in other interest areas such as human factors/usability, investigatory testing, clinical tool design & development, and product labeling.
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 in engineering, preferably with a mechanical background.
• Experience with medical device design controls and quality management systems.
• Practical knowledge of medical device regulatory requirements and standards such as ISO 13485 and/or ISO 14971 is preferred.
• Excellent written and verbal communication and technical documentation skills.
• Strong analytical and interpersonal skills.
• Ability to work as part of a team and independently.
• High degree of drive and motivation.

Compensation
Kardium has listed the total cash compensation range 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.

• $80,000 - $106,000 (CAD Annually)

Your Benefits & Well-being
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.
Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
Career progression and learning support.
Professional membership support.
Life at Kardium
What makes us a great place to work?
Our Purpose Our People Our Culture
Patient first ​ Brilliant ​ Excellence
Innovation ​ Achievers​ Communication
Quality Trust ​ Decision making ​
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, 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

As a Systems Engineer, you will be an integral part of our multidisciplinary engineering team, working across the mechanical, regulatory, usability, and risk management domains. Your daily activities will center around supporting requirements management and product design and development. Your core responsibilities will include:

• Managing product design requirements, and communicating those with risk management, regulatory affairs, design, and test engineering teams
• Ensuring design controls are appropriately applied and documented during product development
• Supporting the risk management process by developing requirements that mitigate system risks
• Investigating issues identified during verification and clinical use of the device, and as a subject matter expert, driving resolution with interdisciplinary teams
• Becoming familiar with and staying current on relevant medical device standards and regulation

You will be successful in this role because you possess these attributes:

• Bachelor’s degree in engineering, preferably with a mechanical background.
• Experience with medical device design controls and quality management systems.
• Practical knowledge of medical device regulatory requirements and standards such as ISO 13485 and/or ISO 14971 is preferred.
• Excellent written and verbal communication and technical documentation skills.
• Strong analytical and interpersonal skills.
• Ability to work as part of a team and independently.
• High degree of drive and motivation