Software Verification Team Lead, MDS Release (Hybrid)
Top Benefits
About the role
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 regulatory approvals and on track for commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
The Software Verification Team is seeking a MDS Release Team Lead to support verification and validation activities for Kardium’s flagship product. This role will be critical in ensuring that the Globe System and associated software comply with industry regulations. The MDS Release role will lead the efforts for Globe Software releases and patches to ensure that our product software is regulatory compliant and supports our commercial sites. The role will have a pivotal impact on the quality and frequency of Globe Software releases, ensuring that verification is done early and efficiently in the release cycle.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of
Plan scope of V&V:
- Coordinate with team leads and requirements document owners and participate in risk management activities to identify required V&V activities.
- Ensure that our SRS and SDS documents are verifiable.
Furthermore:
- Prioritize, schedule, track, and conduct verification activities in coordination with stakeholders.
- Work with stakeholders from Risk, Manufacturing and Regulatory Teams to support Globe patching and regression analysis.
- Develop and execute comprehensive verification and validation plans and procedures for medical devices, ensuring adherence to applicable standards and regulations (e.g., IEC 62443, FDA GPSV)
- Drive generation and maintenance of V&V documentation, including TPs, TRs, design verification reviews, and tracking documents, traceability upkeep and matrices, as well as high‐level planning documents and high‐level reports to support regulatory submissions.
- Participate in design and requirement reviews to ensure full SRS verification coverage.
- Stay up to date with changes in regulations, standards, and best practices, ensuring the company’s products remain compliant.
- Provide mentorship to team members.
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 of Science or Engineering degree
- Practical, hands-on experience in design or Software test engineering
- Multidisciplinary understanding of medical device system
- Practical knowledge of medical device regulations and industry standards (FDA, IEC 62304, ISO 14971, etc.).
- Excellent communication and documentation skills
- Flexible and adaptable to take on additional responsibilities as appropriate
- Familiarity with software development lifecycles (SDLC) and Agile methodologies.
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.
- $116,000- $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?
- Our Purpose
- Our People
- 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!
Software Verification Team Lead, MDS Release (Hybrid)
Top Benefits
About the role
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 regulatory approvals and on track for commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
The Software Verification Team is seeking a MDS Release Team Lead to support verification and validation activities for Kardium’s flagship product. This role will be critical in ensuring that the Globe System and associated software comply with industry regulations. The MDS Release role will lead the efforts for Globe Software releases and patches to ensure that our product software is regulatory compliant and supports our commercial sites. The role will have a pivotal impact on the quality and frequency of Globe Software releases, ensuring that verification is done early and efficiently in the release cycle.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of
Plan scope of V&V:
- Coordinate with team leads and requirements document owners and participate in risk management activities to identify required V&V activities.
- Ensure that our SRS and SDS documents are verifiable.
Furthermore:
- Prioritize, schedule, track, and conduct verification activities in coordination with stakeholders.
- Work with stakeholders from Risk, Manufacturing and Regulatory Teams to support Globe patching and regression analysis.
- Develop and execute comprehensive verification and validation plans and procedures for medical devices, ensuring adherence to applicable standards and regulations (e.g., IEC 62443, FDA GPSV)
- Drive generation and maintenance of V&V documentation, including TPs, TRs, design verification reviews, and tracking documents, traceability upkeep and matrices, as well as high‐level planning documents and high‐level reports to support regulatory submissions.
- Participate in design and requirement reviews to ensure full SRS verification coverage.
- Stay up to date with changes in regulations, standards, and best practices, ensuring the company’s products remain compliant.
- Provide mentorship to team members.
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 of Science or Engineering degree
- Practical, hands-on experience in design or Software test engineering
- Multidisciplinary understanding of medical device system
- Practical knowledge of medical device regulations and industry standards (FDA, IEC 62304, ISO 14971, etc.).
- Excellent communication and documentation skills
- Flexible and adaptable to take on additional responsibilities as appropriate
- Familiarity with software development lifecycles (SDLC) and Agile methodologies.
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.
- $116,000- $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?
- Our Purpose
- Our People
- 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!