Engineer, Associate (Test Engineering & Product Release) - Point of Care (Ottawa)
Core
Associate Engineer supporting product and component lot releases, ensuring product quality and performance in a regulated manufacturing environment.
Role type
Associate Test Engineering & Product Release Engineer
Builds
Finished goods and diagnostic components for Point of Care medical devices
Domain
Healthcare diagnostics / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, CAPA execution, statistical data analysis, GMP compliance, technical reporting, cross-functional collaboration, project management, risk management (FMEA), Lean Six Sigma principles
Preferred skills
statistical software (Minitab, JMP, SPC), regulated manufacturing experience, infectious disease/cardiometabolic domain knowledge
Technologies
Minitab, JMP, SPC
Responsibilities
Assemble and prepare monthly/quarterly metric data reviews for quality systems, drive lot releases through data review and investigation, investigate manufacturing/product/quality issues, perform technical investigations and root cause analysis, support implementation of product/process/documentation changes, prepare and maintain technical reports and quality documentation, participate in continuous improvement initiatives for quality/efficiency/yield/cost
Seniority
Junior to Mid-level, hands-on IC