Biomedical Technology Specialist
2 months ago
Position Overview
The Biomedical Technology Specialist plays a crucial role in assessing, testing, calibrating, programming, and repairing prototypes and products at Breathe BioMedical. This position also involves operating and maintaining the company's advanced laser technology platform.
Interaction and Collaboration
This role requires collaboration with all levels of staff and management within Breathe BioMedical. Externally, the specialist will engage with industry organizations, consultants, vendors, and various healthcare professionals, including clinical sites.
Quality Assurance
- Consistently meets performance expectations
- Complies with all environmental, health, and safety regulations
Efficiency Standards
- Ensures accurate and efficient work execution
- Adheres to the organization's quality service standards
- Assists in meeting project deadlines
- Collaborates with supervisors to address technical, productivity, safety, or scheduling challenges
Key Responsibilities
- Assembles breath samplers and verifies product conformity according to established blueprints and procedures.
- Documents anomalies and deviations in the quality management system.
- Suggests corrective actions for manufacturing and quality issues related to processes or equipment.
- Participates in production and project meetings, providing feedback to enhance processes and technology.
- Maintains thorough documentation of completed tasks and test results.
- Aids in generating engineering and production documentation.
- Follows defined processes and workflows consistently.
- Contributes design ideas during the design process.
- Assists with various laboratory tasks as needed.
- Conducts maintenance and preventative maintenance as per procedures and diagnoses equipment faults.
- May provide training on operational procedures.
- Enhances professional knowledge through workshops, publications, and networking.
- Supports team objectives by achieving related results.
- Collaborates with the Clinical Team and Clinical Sites to ensure effective breath sample collection.
- May require travel to clinical sites for equipment setup, training, troubleshooting, and coordination.
- Operates hand tools and power tools necessary for electro-mechanical tasks.
- Troubleshoots and repairs Breathe BioMedical equipment.
Educational Requirements
- Diploma in Electro-Mechanical Engineering Technology or Electronics Engineering Technology from an accredited institution.
Experience Requirements
- At least 3 years of relevant experience in a design and production environment.
- Familiarity with FDA, Health Canada, or similar regulatory environments is preferred.
Required Skills
- Proficient in using lab tools and analysis instruments.
- Logical troubleshooting abilities.
- Knowledge of quality management systems for engineering changes.
- Ability to interpret manufacturing drawings.
- Self-motivated with strong initiative.
- Capable of working independently while managing multiple projects and deadlines.
- Strong decision-making capabilities.
- Adheres strictly to procedures, rules, and regulations.
- Proficient in MS Suite, including Word, Excel, PowerPoint, and Visio.
Special Training Requirements
- Completion of New Employee Safety Orientation.
- Workplace First-Aid training; recertification as required.
- WHMIS training; recertification as required.
- Knowledge of ISO standards, particularly ISO13485.
- Valid driver's license required.
- Must be able to obtain a valid passport for travel across North America.
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