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Technologist
Position Objective
The Technologist is responsible for evaluating, testing, calibrating, programming, and repairing Breathe BioMedical prototypes and products; as well as, operating and servicing Breathe BioMedical’s laser technology platform.
Job Interactions and Interface
Internally this position interacts with all employees and management within Breathe BioMedical. Externally this position interacts with industry organizations, consultants, vendors, and a variety of healthcare professionals including clinical sites.
Quality
- Consistently meets all job performance expectations
- Adheres to all environmental, health and safety regulations
Quantity
Ensures work is performed accurately and efficientlyMeets the quality service standards as established by the organizationResponsible for assisting in meeting all deadlinesWorks with supervisor to resolve any technical, productivity, safety or scheduling problemsMain Duties
Conducts breath sampler assembly and product conformance verification according to established blueprints, schematics, procedures and diagrams.Records anomalies and deviations in the quality management system / engineering systems.Proposes corrective actions for resolutions to manufacturing and quality problems due to processes or equipment.Participates in the production and / or project meetings; offering feedback and guidance Breathe BioMedical can use to improve its processes and technology offerings.Prepares and maintains written documentation of completed tasks and electro-mechanical test results.Assists in generating engineering and production documentation.Consistently follows and complies with defined processes and workflows.Contributes design suggestions and ideas into the design process.Assists with various lab work, as needed.Performs maintenance and preventative maintenance in accordance with procedures and diagnoses and repairs faults.May train others on proper operational procedures.Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.Contributes to team effort by accomplishing related results as needed.Interacts with the Clinical Team and Clinical Sites to ensure the successful collection of breath samplesOccasional travel required to clinical sites for breath sampler set-up, training, troubleshooting and coordinationExperience operating hand tools and power tools required for electro and mechanical job requirementsOperating Breath Samplers and SpectrometersTroubleshoot & repairing Breathe BioMedical equipmentEducation
Diploma in Electro-Mechanical Engineering Technology or Electronics Engineering Technology from an accredited post-secondary institutionExperience
Minimum of 3 years relevant work experience in design and production environmentPrior knowledge or experience working with FDA, Health Canada or other related regulatory environmentsSkills
Demonstrates competency in the use of lab tools and debug / analysis instruments.Applies logical thought in troubleshootingDemonstrated knowledge of quality management systems for engineering changesAbility to interpret manufacture drawingsSelf-motivated with a high degree of initiativeAbility to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environmentSolid decision-making skillsMust work precisely according to procedures, rules and regulationsExperience operating hand tools and power tools required for electro and mechanical job requirementsSolid communications skills (verbal, written, listening, conveying messages)Ability to work cohesively within a team environment including at third party clinical and vendor sitesGood knowledge of MS Suite including Word, Excel, PowerPoint, VisioSpecial Job Requirements and / or Training
New Employee Safety OrientationWorkplace First-Aid training; recertify as per training specificationsWHMIS training; recertify as per training specificationKnowledge of and ability to work within ISO standards, specifically ISO13485Holds a valid drivers licenseHolds or can obtain a valid and current passport and is able to travel across North America