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Senior Firmware Developer
2 months ago
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 TestingInvestigate and define software engineering requirements for new algorithms or features – facilitate the transition of algorithms into new projectsHands on involvement in software development, systems integration testing and troubleshooting of technical issuesActing as design responsible engineer (DRE) or as an advisor to more junior EngineersAct as internal leader as subject matter expert (SME) regarding firmware designPerform role of independent design reviewer to ensure high quality, innovative designs are releasedDeliver internal leadership as SME across broad product development tools, techniques, and capabilities to advance our effectivenessActively mentor less experienced engineers to improve their capability and optimize the delivery of electronic medical device designsDevelop and maintain internal and external networks that can be leveraged to advance product development capabilitiesDesign state of the art firmware for new and existing medical devices within an advanced product development processEnsure firmware development lifecycle processes for medical devices are implemented, maintained, and followedEstablish and maintain development environments and libraries for firmware programmingInitiate process improvements to support design and development efficiency and scalability.Planning and Process DevelopmentDefinition, documentation, and control of systems requirements on defined projectsSystem level hardware/software architectureManaging software and systems risk and hazard analysis activities for defined projectsManaging software verification and validation activities for defined projectsDeliver projects on time by establishing scope of work and deadlines and providing regular updates against approved plansComplete all necessary design controlsDrive completion of firmware development lifecycle processes for medical devices are implemented, maintained, and followedContribute to strategic roadmap planning including product and technology roadmaps.Relationship ManagementDeliver 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 developmentCollaborate 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.QUALIFICATIONSDegree 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 commercializationProfessional 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 designDemonstrated experience taking leading roles in cross functional medical device development project teams.Good verbal and written communication skills, including report writing skillsGood interpersonal skillsAbility to work independentlyComputer literate with:Experience in MS Word, MS Excel and MS Project ManagementEmbedded systems design and programming (C and/or C++)Experience using scripting languages such as Python, Java etcCross platform skills (e.g. Two or more of Windows, Linux, MacOS, …)Basic knowledge of respiratory related medical devicesKnowledge of regulatory requirements applicable to new product development, e.g., ISO Design Controls, FDA GMP and HPB requirementsKnowledge 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) requirementsCreative problem-solving skillsAt an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.
