Senior Systems Engineer, New Product Development

by Trudell Medical International

Position Type: Full-time
Location: London, ON
Date Posted: Oct 04, 2021
Trudell Medical International

Job Description

 

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 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:
  • 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

 
If you interested in this employment opportunity, please apply through LinkedIn
 

At the applicant's request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.
Please send your résumé only once per position.
Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted.
TMI is an equal opportunity employer.
We thank all applicants in advance for their interest in joining our team.