Tooling Validation Engineering Specialist

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.

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.

• 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

• 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

• 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

• 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

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

• 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
• Six Sigma or Lean Manufacturing certification is an asset
• Proficiency with GD&T, tolerance stack-up analysis, and 3D CAD software
• Excellent problem-solving, documentation, and communication skills
• Proficiency in CAD tools and Solid Works
• Strong understanding of plastic materials and manufacturing processes

Trudell Medical International is committed to providing fair and equitable compensation opportunities to all teammates. The range displayed on each job posting reflects the target for new hire salaries for the advertised position. Within the range, individual compensation is determined by job-related skills and knowledge, relevant professional, lived experience, and/or work location. Our compensation policies and practices are designed to allow our colleagues’ growth and salary progression as they develop in their role.

As a candidate, you are encouraged to ask compensation-related questions and have an open dialogue with your recruiter, who can provide specific details for this role and share more information about our total rewards package.

As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. All final hiring decisions are made by our recruitment team.

We are an equal opportunity employer and it is important to our Company that all its employees, including those with disabilities, find our workplace to be welcoming and supportive. If you are a candidate with a disability who requires accommodations during the recruitment process, please let us know.