Senior Systems Engineer, New Product Development

Senior Systems Engineer, New Product Development

• 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.

• 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.

• 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.

• 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.

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

• Degree in Engineering (Systems, Mechanical, Biomedical, Electrical or Software/firmware.
• At least 8-10 year's 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
  • Intermediate experience in MS Excel
  • Intermediate experience in MS Project Management
  • Intermediate experience in MoldFlow
  • 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, such as ISO-9001 design controls, FDA, GMP and Therapeutic Products Directorate (TPD) requirements
• Creative problem-solving skills