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Added 10 mins ago
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Trudell Medical International

Product Development Engineering Specialist

Waterloo, ON, Canada

Pay: $80,000 to $95,000 CAD / year
Job type: Full-time
Apply by: Oct 23, 2026
Experience: 5-10 years of product development and design experience
Posting language: English
Posted: Sep 23, 2026

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Applications open in a new tab.

Original job description

Job Purpose:

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.

Key deliverables:

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 new 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

Collaboration

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
5-10 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.)
Analysis (Risk, Tolerances, Statistical, Root Cause, 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.)
Materials selection (Polymers, additives, properties, safety, etc.)
Costing (COGS)
Prototyping (3D Printing, Electronics, Traditional, etc.)
Programming (Python, Matlab, Arduino…etc.)
Electronics (prototype PCB or breadboard, component selection, test, etc.)
Experience with mentoring and leading teams
Project management experience
Proficient with tools and techniques of medical device design

Apply About employer

More about this job

Responsibilities

Lead mechanical development and contribute to the technical direction and system integration of advanced medical device programs, including architecture, interfaces, verification, and manufacturing transfer. Serve as a Design Responsible Engineer, maintain design controls, support regulatory compliance, and contribute to product lifecycle and process improvement activities.

Requirements

Requires an engineering degree in mechanical, mechatronic, biomedical, or a related field, along with 5–10 years of product development and design experience. Candidates should have hands-on experience taking mechanical products from concept through verification and manufacturing transfer; medical device or similarly regulated industry experience is an asset.

Skills

Mechanical Product Development
Electromechanical Design
CAD
Risk Analysis
Tolerance Analysis
Root Cause Analysis
FEA
CFD
Design Verification And Validation
Design For Manufacture
Materials Selection
Prototyping
Python
MATLAB
Electronics Prototyping
Project Management

Visa sponsorship

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Keywords

Medical Devices
Product Development
Mechanical Engineering
Electromechanical Design
Product Architecture
System Integration
Design Responsible Engineer
Product Design Specification
Design Controls
Intellectual Property
Invention Disclosures
CAD
PDM
Risk Analysis
Tolerance Analysis
Statistical Analysis
Root Cause Analysis
FEA
CFD
Design Verification And Validation
Design For Manufacture
Materials Selection
Cost Of Goods Sold
3D Printing
Python
MATLAB
Arduino
Prototype Electronics
Manufacturing Transfer
Regulatory Compliance

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