Tooling Validation Engineering Specialist

Company Overview

Trudell Medical International (TMI), based in London, Ontario, Canada, is dedicated to creating impactful medical devices through innovation and creativity. The company fosters a respectful, family-focused, and comfortable workplace within a modern facility.

Role Summary

The Tooling Validation Engineering Specialist will lead the evaluation and qualification of new or modified production tooling. The role ensures all tools meet design intents, specifications, and quality standards prior to manufacturing release, while managing project timelines, requirements, and deadlines.

Key Responsibilities

• Analyze tooling designs, CAD models, and technical drawings efficiently.
• Perform dimensional inspections and capability studies on initial and sample parts.
• Collaborate with toolmakers and engineers to verify tooling performance against design requirements.
• Utilize metrology instruments such as CMMs, laser scanners, and gauges for precision verification.
• Develop and implement validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) where relevant.
• Prepare and maintain tooling project plans.
• Conduct root cause analyses and implement corrective actions for tooling-related challenges.
• Support mold trials, troubleshoot tooling, and aid process enhancements.
• Document validation outcomes and ensure the traceability of tooling modifications.
• Collaborate cross-functionally with product development, quality assurance, procurement, and manufacturing teams to promote smooth tooling integration and meet deadlines internally and with suppliers.
• Coordinate with external tool suppliers and shops on tool trials and necessary improvements.
• Offer technical assistance during production scale-up and address post-launch issues.
• Work alongside subject matter experts in product development to fully comprehend product functionality, enabling mechanical design adjustments without affecting performance.
• Ensure all projects comply with applicable standards, regulations, and policies to secure product clearances, and proactively challenge regulations when suitable.
• Adhere to health and safety regulations including the Workplace Safety and Insurance Act and Occupational Health and Safety Act.

Qualifications and Experience

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related discipline.
• At least 5 years of experience in tooling, mold validation, or precision manufacturing.
• Comprehensive knowledge of injection molding processes, as well as die casting and stamping methods.
• Familiarity with metrology devices and statistical tools like Minitab and Statistical Process Control (SPC).
• Expertise in Geometric Dimensioning and Tolerancing (GD&T), tolerance stack-up analysis, and mold flow simulations.
• Experience in validating tooling for regulated industries such as automotive or medical devices.
• Certifications in Six Sigma or Lean Manufacturing are advantageous.
• Proficiency with CAD design software, especially SolidWorks.
• Strong understanding of plastic material properties and manufacturing techniques.
• Knowledge of ISO 9001, ISO 13485, IATF 16949, or equivalent quality management standards.
• Excellent analytical, documentation, and communication abilities.

Additional Information

Trudell Medical International strives to offer equitable compensation, based on skills, experience, and location. Candidates are encouraged to discuss compensation openly during the recruitment process. AI tools may assist with candidate screening, but hiring decisions are finalized by recruitment staff. The company is an equal opportunity employer committed to providing an inclusive and accessible workplace; accommodations can be offered for candidates with disabilities during recruitment.