Medical Device Regulatory jobs in Vancouver, BC

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 obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients!
The Continuous Improvement team is responsible for the implementation of continuous improvement programs to drive operational excellence across the operations environment.
As a Continuous Improvement Engineer, you will lead cross-functional projects from initiation to completion and track project metrics to project targets. This role will deliver assigned projects and work with other stakeholders to achieve desired results in cost saving and efficiency improvements.
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:

• Lead high-impact, cross-functional continuous improvement initiatives to enhance manufacturing throughput, quality, cost performance, and operational scalability.
• Lead value stream mapping and implementation of Lean flow principles in a regulated operational environment.
• Establish and embed standard work, visual management, performance metrics, and tiered accountability systems to improve operational maturity.
• Collect data and analyze the use of equipment, materials and labor across operational processes.
• Facilitate advanced root-cause investigations using DMAIC, A3, 8D, Fishbone, 5-Why, statistical analysis, and data modelling techniques.
• Apply structured problem-solving methodologies to stabilize operations, resolve systemic production issues, and implement sustainable corrective actions.
• Work closely with Production, Supply Chain, Quality, EHS, Facilities, Planning, and R&D to standardize base processes and identify improvement opportunities.
• Communicate effectively on status of the projects to all levels of the organization.
• Provide training and mentorship to cross-functional teams in lean six sigma principles and tools as well as adoption of best practices to drive continuous improvement culture.

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 a relevant discipline (Biomedical, Mechanical or Industrial Engineering, etc).
• 3 to 6 years of relevant experience; however, we welcome candidates with varying levels of experience.
• Six Sigma Green Belt Certification (ASQ-CSSGB).
• Highly analytical with the ability to structure and interpret operational data using data analytics tools to support data-driven decision making.
• Knowledge and experience with FDA cGMP regulations an asset.
• Proven experience and success implementing lean-six sigma and cost reduction.
• Strong facilitation and relationship building skills across the organization.
• Ability to prioritize, multitask and lead multiple projects simultaneously.

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.

• $87,000 – $110,000 (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?
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!