Your opportunity

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.

Meaningful work you will be a part of

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

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.

• $80,500 - $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.