Job Purpose:

The Senior 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 provides technical leadership for mechanical product architecture, physical and fluidic interfaces, external development activities, verification, manufacturing implementation, and product lifecycle support.

The role will establish the mechanical design direction, coordinate mechanical work performed internally and externally, and ensure that detailed designs implement the intended architecture and product requirements.

Working closely with the Engineering Manager, Project Management, the program DRE or Technical Lead, and cross-functional teams, the successful candidate will help develop and mature Trudell’s internal mechanical engineering capability. The role provides technical leadership while working collaboratively with these functions to deliver program objectives and is expected to influence technical direction through engineering expertise rather than formal people management.

Key deliverables:

Design Development & Testing

- Design efficient and effective mechanical and electromechanical systems and sub-systems to support product design. Acting as design responsible engineer (DRE) or as an advisor to more junior Engineers
- Actively mentor less experienced engineers to improve their capability and optimize the delivery of medical device designs




- Develop and maintain internal and external networks that can be leveraged to advance product development capabilities

Development Process

- Lead and/or advise on multiple different invention disclosures including for recent technologies or systems
- Lead and/or advise on development of multiple project plans and/or where planning expertise is required to address deep uncertainty or new areas of development
- Lead continuous improvement teams and deliver on continuous improvement initiatives that improve aspects of the new product development process
- Initiate lessons learned processes at points during the product development process in order to capture opportunities for improvement

Collaboration

- Collaboration with the SEED team to transfer product ideas into Phase 1 of product development
- Collaborate with the Marketing and Sales department to investigate incremental business ideas to capture the voice of the customer and develop a business case for strategic review

Regulatory & Policy

- Deliver development of complicated products and/or systems to achieve regulatory clearance and policy compliance
- Identify opportunities for improvement to regulatory related activities to optimize product development and improve effectiveness

Health & Safety





- Comply with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
- Identify areas for improvement with regards to Health and Safety within product development

Education & Experience:

1. Degree in Engineering (Mechanical, Mechatronic, Biomedical) or a related field of study
2. 10-15 years of product development and design experience
3. Experience working in a regulated industry an asset, e.g. medical device, pharmaceutical or aerospace
4. Demonstrated hands-on experience taking mechanical products from concept through detailed development, verification and manufacturing transfer
5. Experience providing technical direction and reviewing work performed by other engineers, consultants or external development partners
6. Experience leading or influencing technical development activities within multidisciplinary engineering teams

Specialized Skill or Knowledge:

1. CAD (Parts, Assemblies, Drawings, PDM, etc.)
2. Analysis (Risk, Tolerances, Statistical, Root Cause, etc.)
3. Modelling and Simulation (FEA, CFD, Mathematical, etc.)
4. Design Verification and Validation (Test Design, Functional, Usability, Compliance, etc.)
5. Design for Manufacture (molding, automated assembly, packaging, etc.)
6. Prototyping (3D Printing, Electronics, Traditional, etc.)
7. Programming (Python, Matlab, Arduino, etc.)
8. Knowledge with electronics (prototype PCB or breadboard, component selection, test, etc.)
9. Leadership and Mentoring skills
10. Project management experience

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