Senior Systems Engineer

About the job

As a member of the Science and Technology team, you will lead and deliver on system level product (hardware/software) architecture concept definitions and implementations for New Product Development projects.

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 systems engineering
• Mentorship and peer development of more junior biomedical, mechanical, and electrical engineers
• Investigate and define systems engineering requirements for new algorithms or features – facilitate the transition of algorithms into new projects
• Hands on involvement in 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 systems risk and hazard analysis activities for defined projects
• Managing systems verification and validation activities for defined
• Investigate and define systems engineering requirements for new algorithms or features – facilitate the transition of algorithms into new projects

Compliance

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

Regulatory Submissions

• Ensure accurate and efficient coordination of the internal process related to the preparation of all materials required in regulatory submissions, inspections, license renewals, and annual registrations
• Prepare, submit, and track regulatory submissions and assist in gathering information for pending regulatory submissions

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 (Systems, Mechanical, Biomedical, Electrical or Software/Firmware)
• At least 8-10 years’ experience in systems engineering roles – proven track record taking devices from concept to registration and commercialization
• At least 5 years’ experience in medical device industry – hands on systems 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:

• Intermediate experience in MS Word, MS Excel, MS Project Management, Mold Flow
• Advanced experience in SolidWorks CAD software
• 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 (e.g., ISO-9001 design controls, 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.