Senior Systems Engineer, New Product Development
As a member of our Science & 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
- 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