Tooling Validation Engineering Specialist

Trudell Medical Group•London, ON

53d

About The Position

At Trudell Medical International (TMI), we pride ourselves on our passion for finding innovative and creative solutions which has enabled us to develop medical devices that continue to make a difference in the lives of people around the world. Situated within a modern facility located in beautiful London, Ontario, TMI offers a comfortable work environment with a respectful and family-oriented culture. As an employee of Trudell Medical International, not only will you contribute to the development of products at the cutting edge of medical device technology, but you will also have the opportunity to perform challenging work alongside a first-rate group of dedicated professionals. We’re actively searching for our next team member for the position of: Tooling Validation engineering Specialist Lead the evaluation and qualification of new and modified tooling used in production. Ensure that all tools meet design intent, performance specifications, and quality standards before release to manufacturing. Successfully monitor project status and adherence to schedules, requirements, and deadlines.

Requirements

Degree in Mechanical Engineering, Manufacturing Engineering, or related field
5+ years of experience in tooling, mold validation, or precision manufacturing
Strong understanding of injection molding, with die casting and stamping processes
Experience with metrology tools and statistical analysis (e.g., Minitab, SPC)
Knowledge of GD&T, tolerance stack-up, and mold flow analysis
Experience with validation in regulated industries (e.g., automotive, medical devices).
Familiarity with mold flow analysis and simulation tools
Knowledge of ISO 9001, ISO 14385, IATF 16949, or similar quality systems
Excellent problem-solving, documentation, and communication skills
Proficiency with GD&T, tolerance stack-up analysis, and 3D CAD software
Proficiency in CAD tools and SolidWorks
Strong understanding of plastic materials and manufacturing processes

Nice To Haves

Six Sigma or Lean Manufacturing certification is an asset

Responsibilities

Tooling Verification
Review and interpret tooling designs, CAD models, and technical drawings
Initiate dimensional inspections and capability studies on first-off and sample parts
Collaborate with toolmakers and design engineers to validate tool performance against specifications
Initiate the use of metrology equipment (e.g., CMM, laser scanners, gauges) to verify part and tool accuracy
Tooling Validation
Develop and execute validation plans including IQ/OQ/PQ protocols, where applicable
Create and update tooling project plans
Perform root cause analysis and corrective actions for tooling-related issues
Support mold trials, tool debug, and process optimization activities
Document validation results and maintain traceability of tooling changes
Cross-Functional Collaboration
Work closely with product development, quality, procurement, and manufacturing teams to ensure seamless tool integration and ensure timelines are met, both internally and with suppliers
Interface with suppliers and external tool shops to coordinate tool trials and improvements
Provide technical support during production ramp-up and post-launch troubleshooting
Working with Product Development SMEs, develop deep understanding of product function to aid in mechanical design changes without functional impact
Regulatory and Policy
Deliver projects in full compliance to all applicable standards, regulations, and policy to achieve clearance
Adapt to and challenge regulations as appropriate to find the best path to clearance
health & Safety
Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.