Systems Engineer (Hybrid) at Kardium Inc.

Burnaby, British Columbia, Canada -

Full Time

Start Date

Immediate

Expiry Date

24 Aug, 26

Salary

101000.0

Posted On

26 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Controls, Risk Management, Technical Documentation, Medical Device Standards, ISO 13485, ISO 14971, Change Control, Design Transfer, Analytical Skills, Interpersonal Skills, Mechanical Engineering Concepts, Regulatory Affairs

Industry

Medical Equipment Manufacturing

Description

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 – a revolutionary solution designed by our world-class technical team. The Globe System offers strong, unique, and customer-valued advantages over other treatments on the market, and leading physicians are already using it and helping to share 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! 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 Development Engineering teams. As a Systems Engineer, you will be working across the technical, regulatory, human factors, testing, and risk management domains. Your daily activities will centre around various aspects of design controls. Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC. What you’ll be doing Your responsibilities will include: Managing product and system design requirements with input from risk management, regulatory affairs, design, and test engineering teams Ensuring design controls are appropriately applied and documented during product development, and carrying out design transfer activities to manufacturing requirements Supporting change control processes for mechanical hardware Supporting the risk management process by developing requirements that mitigate system risks Investigating issues identified during testing and clinical use of devices, and as a subject matter expert, driving resolution with interdisciplinary teams Becoming familiar with and staying current on relevant medical device standards and regulations 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 Understanding of technical mechanical concepts and medical systems Minimum 4 years’ experience with medical device design controls and quality management systems. Practical knowledge of medical device regulatory requirements and standards such as ISO 13485 and ISO 14971 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 (base salary + 5% Retirement Savings Plan 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. $75,000 – $101,000 (CAD Annually) Your Benefits & Well-being The total cash we’ve listed for this position includes a base salary, plus an annual contribution to a Retirement Savings Plan account 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 – we offer a flexible work environment for daily working hours. In addition, we provide 3 personal days per year. Support for you (and your dependents) overall well-being. Family building – we provide top up for maternity leave, adoptive leave, and parental leave for non-birthing parents. 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 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 ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Irish ERG, Brazilian ERG, and Early Career at Kardium 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!

Responsibilities

Manage product and system design requirements while ensuring design controls are documented during development. Collaborate with interdisciplinary teams to mitigate system risks and resolve issues identified during testing and clinical use.