Technologist

6 months ago

Moncton, Canada Breathe BioMedical Full time

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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 efficiently Meets the quality service standards as established by the organization Responsible for assisting in meeting all deadlines Works with supervisor to resolve any technical, productivity, safety or scheduling problems

Main 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 samples Occasional travel required to clinical sites for breath sampler set-up, training, troubleshooting and coordination Experience operating hand tools and power tools required for electro and mechanical job requirements Operating Breath Samplers and Spectrometers Troubleshoot & repairing Breathe BioMedical equipment

Education

Diploma in Electro-Mechanical Engineering Technology or Electronics Engineering Technology from an accredited post-secondary institution

Experience

Minimum of 3 years relevant work experience in design and production environment Prior knowledge or experience working with FDA, Health Canada or other related regulatory environments

Skills

Demonstrates competency in the use of lab tools and debug/analysis instruments. Applies logical thought in troubleshooting Demonstrated knowledge of quality management systems for engineering changes Ability to interpret manufacture drawings Self-motivated with a high degree of initiative Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment Solid decision-making skills Must work precisely according to procedures, rules and regulations Experience operating hand tools and power tools required for electro and mechanical job requirements Solid communications skills (verbal, written, listening, conveying messages) Ability to work cohesively within a team environment including at third party clinical and vendor sites Good knowledge of MS Suite including Word, Excel, PowerPoint, Visio

Special Job Requirements and/or Training

New Employee Safety Orientation Workplace First-Aid training; recertify as per training specifications WHMIS training; recertify as per training specification Knowledge of and ability to work within ISO standards, specifically ISO13485 Holds a valid drivers license Holds or can obtain a valid and current passport and is able to travel across North America

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