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Senior Firmware Developer

2 months ago

London, Canada Trudell Medical International Full time

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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