The Product Development Engineering Specialist is responsible for leading the mechanical development activities for advanced medical device programs while contributing to the overall technical direction and system integration of the product.

The role delivers on mechanical product architecture, physical and fluidic interfaces, external development activities, verification, manufacturing implementation, and product lifecycle support.

The role will support the establishment of the mechanical design direction and ensure that detailed designs implement the intended architecture and product requirements. The role works collaboratively with the Engineering Manager, Project Management, the program DRE or Technical Lead, and cross-functional teams to deliver program objectives.

Design Development & Testing

With oversight from Senior, Principal Engineer or Product Development Project Lead, design mechanical or electromechanical solutions to support device design

Act as Design Responsible Engineer (DRE) and maintain and create the Product Design Specification and all design controls

Apply standardized problem-solving tools to identify a design problem and propose solutions before implementation

Development Process

Develop full invention disclosures within the Intellectual Property development process as lead inventor

Develop complete project plans that accurately reflect the scope and deliverables required for a given project

Deliver continuous improvement initiatives that improve aspects of the current product development process as part of a continuous improvement team





Transfer product to manufacturing and revise design/process based on feedback until the product has reached target production yields and throughput

With support from Senior, Principal Engineer or Product Development Project Lead, plan design to achieve a developed product

Coordinate with Product Development Project Lead to align design and development tasks to the overall project plan

Regulatory & Policy

Deliver device development projects in full compliance with all applicable standards, regulations, and policies 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.

Education & Experience:

Degree in Engineering (Mechanical, Mechatronic, Biomedical) or a related field of study

1. 10 years of product development and design experience

Medical device industry experience, or a similarly regulated field, is an asset

Demonstrated hands‐on experience taking mechanical products from concept through detailed development, verification and manufacturing transfer

Specialized Skill or Knowledge:

CAD (Parts, Assemblies, Drawings, PDM, etc.)

Modelling and Simulation (FEA, CFD, Mathematical, etc.)

Design Verification and Validation (Test Design, Functional, Usability, Compliance, etc.)

Design for Manufacture (Molding, automated assembly, packaging, etc.)

Costing (COGS)

Electronics (prototype PCB or breadboard, component selection, test, etc.)

Experience with mentoring and leading teams

Proficient with tools and techniques of medical device design

📌 Product Development Engineering Specialist (Kitchener)
🏢 Trudell Medical International
📍 Kitchener