Systems Engineering Team Lead - Labeling (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 member of the Systems Engineering Team, you will be responsible for leading a team and managing labeling (instructions for use and product identification labels) for the Globe PF System. 

Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

Meaningful work you will be a part of

Your responsibilities will include:

• Manage all technical publications timelines and deliverables relating to key milestones, including management of labeling and document change requests, translation, and standard compliance 

• Develop and continuously improve systems and procedures required to support the management of the product labeling, including transfer of labeling to production 

• Develop, coordinate, and communicate labeling strategy with Engineering, RA, Clinical Operations, Manufacturing, QA, Document Control, and Logistics 

• In collaboration with Systems Engineering, Regulatory Affairs and other stakeholders, manage design input requirements for labeling in compliance with applicable regulatory requirements, standards and internal procedures 

• Collaborate with cross-functional teams to ensure project deadlines are communicated and met 

• Lead a team of Technical Writers, assign individual responsibilities, develop project schedules, and determine resource requirements for labeling deliverables 

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:

Education & Experience: 

• Bachelor’s degree, preferably in a technical/science field, or equivalent combination of education and experience. 

• Experience managing complex and diverse projects with multiple stakeholders 

• Experience with quality management systems, e.g. MasterControl 

• Experience managing medical device labeling programs, including: source control and content management, translation, and requirements management 

• Understanding of ISO 13485 and ISO 14971  

Requirements & Skills: 

• Understanding of project management and related tools 

• Excellent written and verbal communication and technical documentation skills 

• Strong analytical and interpersonal skills 

• Interest or experience in technical team leadership; setting realistic and attainable goals, providing room for growth, and establishing a shared vision of team objectives. 

• Excellent interpersonal skills, with track-record of driving consensus with diverse stakeholders. 

• Highly organized, detail-oriented, and conscientious 

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.

• $83,000 – $106,000 (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!