Firmware Developer

Responsibilities Include:

Team Leadership, Mentoring and Delivering Results

• Working within new product development, lead cross functional project teams to drive best practice activities in medical device firmware and Software-as-A-Medical (SaMD) engineering.
• Mentorship and peer development of more junior biomedical, mechanical, mechatronics and electrical engineers
• Investigate and define software engineering requirements for new algorithms or features – facilitate the transition of algorithms into new projects.
• Hands on involvement in software development, systems integration testing and troubleshooting of technical issues.

Technical Support

• Definition, documentation, and control of systems requirements on defined projects
• System level hardware / software architecture
• Managing software and systems risk and hazard analysis activities for defined projects
• Managing software verification and validation activities for defined projects
• Investigate and define software engineering requirements for new algorithms or features – facilitate the transition of algorithms into new projects.

Compliance

• Carry out design development activities in full accordance with TMI’s Quality Policy and Procedures
• Ensure the products are developed to meet all regulatory requirements including design controls.

Health and Safety

• Comply with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

QUALIFICATIONS

• Degree in Engineering (Computer Science, Software, Systems, Electrical, Biomedical or Mechatronics).
• At least 4-8 years’ experience in firmware engineering roles – proven track record taking devices from concept to registration and commercialization.
• At least 2 years’ experience in medical device industry – hands on firmware development experience including needs definition, use case workflows, requirements definition, functional architecture, and system design.
• Demonstrated experience taking leading roles in cross functional medical device development project teams.
• Good verbal and written communication skills, including report writing skills.
• Good interpersonal skills
• Ability to work independently.
• Computer literate with:
• Experience in MS Word, MS Excel and MS Project Management
• Embedded systems design and programming (C and/or C++)
• Experience using scripting languages such as Python, Java etc
• Cross platform skills (e.g. Two or more of Windows, Linux, MacOS, …)
• Basic knowledge of respiratory related medical devices
• Knowledge of regulatory requirements applicable to new product development, e.g., ISO Design Controls, FDA GMP and HPB requirements
• Knowledge of regulatory requirements as they may apply to new product development, such as ISO-9001 design controls (IEC62304), FDA, GMP and Therapeutic Products Directorate (TPD) requirements
• Creative problem-solving skills.

If you interested in this employment opportunity, please apply through LinkedIn

At the applicant's request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.

Please send your résumé only once per position.

Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted.

TMI is an equal opportunity employer.

We thank all applicants in advance for their interest in joining our team.

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