Senior Firmware Developer

About the job

As a member of our Product Development team, you will design, implement, maintain, and document firmware for system level medical products (hardware/software) for new product development projects from concept to complete release to manufacturing.

Responsibilities Include:

Design, Development and Testing

• 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
• Acting as design responsible engineer (DRE) or as an advisor to more junior Engineers
• Act as internal leader as subject matter expert (SME) regarding firmware design
• Perform role of independent design reviewer to ensure high quality, innovative designs are released
• Deliver internal leadership as SME across broad product development tools, techniques, and capabilities to advance our effectiveness
• Actively mentor less experienced engineers to improve their capability and optimize the delivery of electronic medical device designs
• Develop and maintain internal and external networks that can be leveraged to advance product development capabilities
• Design state of the art firmware for new and existing medical devices within an advanced product development process
• Ensure firmware development lifecycle processes for medical devices are implemented, maintained, and followed
• Establish and maintain development environments and libraries for firmware programming
• Initiate process improvements to support design and development efficiency and scalability.

Planning and Process Development

• 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
• Deliver projects on time by establishing scope of work and deadlines and providing regular updates against approved plans
• Complete all necessary design controls
• Drive completion of firmware development lifecycle processes for medical devices are implemented, maintained, and followed
• Contribute to strategic roadmap planning including product and technology roadmaps.

Relationship Management

• Deliver business objectives by working collaboratively with internal and external parties, e.g., mechanical engineering, core teams, outside contractors, etc.
• Collaboration with SEED team to transfer product idea into Phase 1 of product development
• Collaborate with Marketing/Sales to investigate incremental business ideas to capture the voice of the customer and develop a business case for strategic review.

Health and Safety

• Ensure compliance 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)
• 10+ years of experience in firmware engineering roles – proven track record taking devices from concept to registration and commercialization
• Professional Engineer (P.Eng) and in good standing with Professional Engineers Ontario (PEO)
• 2 years of 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

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

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