Product Development Engineering Specialist

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

1. Degree in Engineering (Mechanical, Mechatronic, Biomedical) or a related field of study
2. 5-10 years of product development and design experience
3. Medical device industry experience, or a similarly regulated field, is an asset
4. CAD (Parts, Assemblies, Drawings, PDM, etc.)
5. Analysis (Risk, Tolerances, Statistical, Root Cause, etc.)
6. Modelling and Simulation (FEA, CFD, Mathematical, etc.)
7. Design Verification and Validation (Test Design, Functional, Usability, Compliance, etc.)
8. Design for Manufacture (Molding, automated assembly, packaging, etc.)
9. Materials selection (Polymers, additives, properties, safety, etc.)
10. Costing (COGS)
11. Prototyping (3D Printing, Electronics, Traditional, etc.)
12. Programming (Python, Matlab, Arduino…etc.)
13. Electronics (prototype PCB or breadboard, component selection, test, etc.)
14. Experience with mentoring and leading teams
15. Project management experience
16. Proficient with tools and techniques of medical device design

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.