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 advanced laser technology platform utilized by the company.
Interactions and Collaboration
This role requires effective collaboration with all levels of staff and management within Breathe BioMedical. Externally, the specialist will engage with industry organizations, consultants, vendors, and a diverse range of healthcare professionals, including those at clinical sites.
Quality Assurance Responsibilities
- Consistently meets performance expectations.
- Complies with all environmental, health, and safety regulations.
Efficiency and Productivity
- Ensures tasks are executed accurately and efficiently.
- Adheres to quality service standards set by the organization.
- Aids in meeting all project deadlines.
- Collaborates with supervisors to address any 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 within the quality management system.
- Suggests corrective actions for manufacturing and quality issues related to processes or equipment.
- Participates in production and project meetings, providing valuable feedback to enhance processes and technology.
- Maintains comprehensive documentation of completed tasks and test results.
- Assists in the creation of engineering and production documentation.
- Follows defined processes and workflows diligently.
- Contributes innovative design ideas during the design process.
- Supports various laboratory tasks as required.
- Conducts maintenance and preventative maintenance as per established procedures and resolves faults.
- May provide training to others on operational procedures.
- Enhances professional and technical knowledge through workshops and participation in professional societies.
- Contributes to team success 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 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 other regulatory environments is preferred.
Required Skills
- Proficient in using laboratory tools and analysis instruments.
- Logical approach to troubleshooting.
- Knowledgeable in quality management systems for engineering changes.
- Ability to interpret manufacturing drawings.
- Self-driven with a strong initiative.
- Capable of working independently while managing multiple projects and deadlines in a hands-on environment.
- Strong decision-making abilities.
- Must adhere to procedures, rules, and regulations precisely.
- Experience with hand tools and power tools for electro-mechanical tasks.
- Excellent communication skills (verbal, written, listening).
- Ability to work effectively within a team, including at third-party clinical and vendor sites.
- Proficient in MS Office Suite, including Word, Excel, PowerPoint, and Visio.
Special Requirements and Training
- Completion of New Employee Safety Orientation.
- Workplace First-Aid training; recertification as per training specifications.
- WHMIS training; recertification as per training specifications.
- Knowledge of ISO standards, specifically ISO13485.
- Valid driver's license required.
- Must possess or be able to obtain a valid passport for travel across North America.
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