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Engineering Technician

Fluid Biotech

Fluid Biotech

Software Engineering
Calgary, AB, Canada
Posted on Saturday, June 1, 2024

This is a unique opportunity to join an early-stage company to advance the development of a novel implantable medical device, ensuring its readiness for human use. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. The Engineering Technician will be overlapping responsibilities across Biomedical Engineering, Quality Engineering, and Manufacturing Engineering for document preparation and execution (protocols, test methods, work instructions, and reports) and data entry and analysis as well as product inspection, material testing/evaluation, and manufacturing processes. The Engineering Technician will work in a fast paced and dynamic environment where collaborating cross-functionally is critical for success.

Key Responsibilities

1. Prototype Assembly and Testing:

  • Assist engineers and researchers in assembling prototypes of biomedical devices and systems (including fixtures and accessories) according to established procedures, specifications, and/or standards
  • Conduct testing and validation experiments on prototypes, collect data, and assist in data analysis
  • Assist in the documentation of experimental results and development of lab reports

2. Quality Assurance and Documentation:

  • Perform product test/inspection activities, including the development of inspection/test reports and ensure they meet quality standards and specifications
  • Adhere to standard Quality Management System (QMS) practices to ensure compliance with regulatory requirements
  • Document all experimental procedures, test results, and observations in laboratory notebooks and electronic databases

3. Manufacturing Engineering:

  • Perform and contribute significantly to the scale-up manufacturing activities including receiving, in-process assemblies, cleaning, packaging, and sterilization processes

4. Laboratory Safety and Compliance:

  • Follow established safety protocols and guidelines to maintain a safe working environment
  • Ensure compliance with applicable regulations, including Good Laboratory Practices (GLP), Good Manufacturing Practice (GMP) and Occupational Safety and Health Administration (OSHA) standards, Workplace Hazardous Materials Information System (WHMIS) to ensure proper handling and disposal of hazardous materials

5. Support Activities:

  • Support continuous improvement activities across Design, Quality, and Manufacturing teams
  • Assist in the development of protocols, test methods, manufacturing, and inspection work instructions and lab reports
  • Assist in equipment calibration process including maintenance of calibration/maintenance reports, and coordinate ongoing equipment service or testing, in coordination with the Engineering team
  • Other Engineering support activities as required

Education and Experience Requirements

  • Associate Degree or equivalent in Engineering (e.g., Biomedical, Mechanical, Quality, etc.), or a related field (exceptional new graduates with design or manufacturing exposure will be considered)
  • Hands-on experience with laboratory equipment (e.g., microscopes), calibration, and troubleshooting
  • Strong mechanical aptitude and dexterity for assembling and testing prototypes
  • Excellent organizational skills and attention to detail
  • Ability to work independently and collaboratively in a fast-paced startup environment
  • Effective communication skills for interacting with multidisciplinary teams
  • Competence with MS Office suite software

Preferred Qualifications

  • Bachelor's degree in Biomedical Engineering, or a related field
  • Prior experience in a biomedical research or startup environment
  • Knowledge of regulatory requirements for medical device development, such as FDA regulations (21 CFR Part 820) and/or ISO 13485
  • Familiarity with CAD software for design and documentation purposes

Role will be located physically on-site in Calgary, Alberta and candidates must be legally entitled to work full-time in Canada.

Role will be located physically on-site in Calgary, Alberta and candidates must be legally entitled to work full-time in Canada.