Product Development 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.

PRODUCT DEVELOPMENT ENGINEERING SPECIALIST
Job Purpose
Deliver innovative medical device designs that provide exceptional value to our patients. Demonstrate proficiency with the tools and techniques of medical device design while developing mentoring skills to guide less experienced engineers. Influence functional teams to deliver new product development projects on plan, within target costs, and that meet or exceed our expectations for quality and innovation.

Responsibilities Include
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.

Qualifications
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
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

At an applicant’s request, TMI will…