Title: Systems Designer Location: Montreal, QC Duration: 5+ Months Pay Rate: $50/hr onwards

Duties: Define and document firmware system specification, including hardware/software interface specifications Create and execute firmware design documentation Participate in design reviews Develop and execute firmware verification and validation protocols and reports Perform risk analysis activities related to firmware Establish and maintain traceability between requirements, design, implementation, and testing Support integration testing between firmware, hardware, and system-level functions Support cybersecurity risk assessments and implement security controls within firmware, as applicable Document anomalies, defects, and resolutions throughout the development lifecycle Review and approve design history file (DHF) documentation for completeness and compliance and maintain and update device master records (DMR) Participate in document and change control processes Assist in complaint handling processes, including investigation and trend analysis Support internal and external audit activities (Preparation) Collaborate with manufacturing and supplier quality to resolve production-related issues Support product end-of-life planning and execution, including last-time buys and customer notifications

Skills: Experience in system design in a multi-disciplinary organization. Experience drafting and maintaining DHF (design history file) content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation. Able to support risk analysis (e.g uFMEA etc) and contribute to usability planning and design mitigations. Familiarity with ISO 14971 is required, and IEC 62366 is preferred. Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team. Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders. Must have experience in a regulatory environment with strict compliance. Strong analytical skills and accurate judgment-making skills. Ability to deal effectively with internal and external collaborators. Excellent communications skills; written and verbal. Experience with Windchill, Codebeamer and/or JIRA, or similar.

Education: Bachelor’s degree in engineering or science-related field; biomedical engineering preferred.