Senior Product Development Engineering Specialist

Job Purpose:

Deliver on complex and/or multiple innovative medical device designs that provide exceptional value to our patients. Demonstrate expert proficiency with the tools and techniques of medical device design while mentoring less experienced engineers. Influence cross functional teams to deliver new product development projects on plan, within target costs, and that meet or exceed our expectations for quality and innovation.

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 new 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

Specialized Skill or Knowledge:

1. CAD (Parts, Assemblies, Drawings, PDM, etc.)
2. Analysis skills (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.) Leadership and Mentoring skills
9. Project management experience