Senior Product Development Engineering Specialist

Trudell Medical International; Kitchener; On-site; CAD 120,000 - 170,000; Full time

Job summary

Trudell Medical International is seeking a Senior Product Development Engineering Specialist to lead mechanical development for advanced medical device programs. You will define mechanical architecture, interfaces, and oversee external development, verification, and manufacturing transfer, while guiding lifecycle support.

You will coordinate internal and external mechanical work, ensuring designs implement architecture and product requirements and influence technical direction through

Qualifications

• Degree in Engineering (Mechanical, Mechatronic, Biomedical) or related field.
• Hands-on experience taking mechanical products from concept through detailed development, verification and manufacturing transfer.
• Experience providing technical direction and reviewing work by other engineers or external partners.
• Experience leading technical development activities within multidisciplinary teams.

Responsibilities

• Design efficient mechanical and electromechanical systems and sub-systems to support product design as DRE or advisor.
• Mentor less experienced engineers to improve capability and delivery of medical device designs.
• Develop and maintain internal/external networks to advance product development capabilities.

Skills

CAD

Modeling & Simulation

Design Verification

Design for Manufacture

Electronics knowledge

Education

Engineering degree (Mechanical, Mechatronic, Biomedical) or related field

Tools

PDM

FEA/CFD

PCB prototyping

Job description

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.

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 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:

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

Specialized Skill or Knowledge:

• CAD (Parts, Assemblies, Drawings, PDM, 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.)
• Knowledge with electronics (prototype PCB or breadboard, component selection, test, etc.)