NPI 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.

We’re actively searching for our next team member for the position of:

NPI Specialist
Purpose
As a member of the Operations team, you will drive speed and create consistency in new product launches by collaborating with cross‑functional teams to ensure robust, optimized manufacturing solutions and seamless transition to production.

Responsibilities
Product Design and Development

Intimately understand the design and operating principles of the devices for your assigned product launches

In collaboration with NPD, create and refine NPI project plans and schedules, ensuring that all related tasks are successfully executed according to established deadlines

Leverage Design For Manufacturing (DFM) practices to ensure designs are optimized for manufacturing and cost

Identify risks and trade‑offs during development, analyze their impact, and create strategies to mitigate them, captured in the DFMEA

Coordinate and provide support for Design of Experiments (DoEs) to ensure accurate data collection and analysis

Manufacturing Process Planning and Development

Lead and own development of the Process FMEA document to proactively identify potential points of failure and develop mitigation strategies

Prepare detailed analyses of process gaps and perform the necessary technical validations to ensure processes are optimized and meet standards

Develop and maintain technology and sourcing roadmaps

Drive the collaborative utilization of NPI planning and execution tools by all stakeholders throughout NPIs

Manufacturing Launch Execution

Work hand‑in‑hand with Strategic Sourcing and Supplier Quality to execute against the sourcing roadmap

Plan and analyze internal and supply chain manufacturing capacity and capability aligned to the ramp up plan and marketing forecast

Identify, record and manage risks and opportunities throughout NPIs

Working with the Manufacturing, Manufacturing Engineering, and Warehouse teams to develop floor plans that provide appropriate manufacturing space and material flow to execute production safely, effectively and efficiently

Develop and execute Release To Manufacturing (R2M) plans

Working with Product Development, Manufacturing Engineering and Controls teams, define specifications for manufacturing equipment, including run‑off, FAT and validation requirements

Working with Product Development, Sourcing, and Manufacturing Engineering, to plan materials for process development and equipment validations

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.

Ensure compliance with TMIs health and safety policies and procedures, e.g., neat and orderly work environment, wearing prescribed PPE

Qualifications

Diploma or degree in Industrial, Mechanical, Mechatronics Engineering, Quality Assurance, or a related field of study

5+ years of experience in a high volume manufacturing environment

3 years of experience in launch planning and execution roles;
New Product Introduction

Experience working in a regulated industry is an asset, e.g., pharmaceuticals or aerospace

Computer literate with:

Advanced experience in MS Excel

Advanced experience in MS Word

Advanced experience in a Windows environment

Theoretical and practical knowledge of assembly design and product manufacturing in an ISO 13485 & GMP environment

Experience developing and/or implementing LEAN Manufacturing and/or six sigma initiatives

Experience with project management

Excellent…