Job DescriptionIn 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 ofManaging product and system design requirements with input from risk management, regulatory affairs, design, and test engineering teamsEnsuring design controls are appropriately applied and documented during product development, and carrying out design transfer activities to manufacturing requirementsSupporting change control processes for mechanical hardwareSupporting the risk management process by developing requirements that mitigate system risksInvestigating issues identified during testing and clinical use of devices, and as a subject matter expert,



driving resolution with interdisciplinary teamsBecoming familiar with and staying current on relevant medical device standards and regulationsWhat you bring to the teamUnderstanding of technical mechanical concepts and medical systemsMinimum 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 14971Excellent written and verbal communication and technical documentation skillsStrong analytical and interpersonal skillsAbility to work as part of a team and independentlyHigh degree of drive and motivationCompensation$80,500 – $101,000 (CAD Annually)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.As a permanent employee, you will also participate in Kardium’s stock option plan.BenefitsComprehensive medical & dental coverage for all permanent employees – effective as of Day 1, with no waiting period.Work-day flexibility – we offer a versatile 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.#J-18808-Ljbffr

📌 Systems Engineer (Hybrid) - C$80,500 - C$101,000 A Year (Winnipeg)
🏢 Kardium
📍 Winnipeg