Mechanical Design Engineer

Mechanical Design Engineer

Responsibilities Include:

Design, Development, and Testing

• Meet customer demands and business objectives throughout design process from idea to concept development to production development
• Support business objectives with technical inputs (e.g., assisting in the development of production cost estimates for developmental projects and determining specifications for off-the-shelf components)
• Ensure products are designed to be safe and efficacious for users (e.g., by doing comprehensive analytical evaluations of complex design solutions, identifying and resolving design issues and technical risks)
• Develop new products in an expeditious manner and ensuring all parties involved in the core team are aware of the current project status
• Resolve technical problems related to new and existing products by working with the Tooling Engineering Specialist and collaborating with injection molding vendors during tool development, build, and production
• Maintain all product development documents in an orderly and systematic filing system by working with Document Control staff

Planning and Administration

• Ensure integrity of product designs by maintaining organized project design files

Support and Collaboration

• Resolve technical problems related to new and existing products by collaborating with injection molding vendors during tool development, build, and production
• Ensure products meet customer and business needs by collaborating internally and externally (e.g., marketing, manufacturing engineering, clinical investigators, etc.)
• Accountable for on time delivery of projects by responding to vendor inquiries and technical problems

Health and Safety

• Adhere to all current relevant policies, procedures, and legislation (e.g., QMS)
• Comply with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

Qualifications:

• Degree in Mechanical, Mechatronics, Biomedical Engineering, or a related field of study
• Professional Engineer designation
• At least 5 years of product development and design experience
• Medical device industry experience, or a similarly regulated field, is an asset

Design

• Ability to rigorously analyze complex design solutions, make optimal design decisions, and identify and resolve design risks
• Ability to produce detailed manual and computer assisted design drawings, and specifications of plastic injection-molded parts
• Ability to produce concept renderings of new products and their application
• Ability to prototype mechanical components (e.g., machining, vacuum forming, casting, and painting)
• Experience with ergonomic design
• Experience with modern design techniques including design for assembly (DFA)
• Experience with high volume molding processes, tool construction, and material selection

Project Management

• Experienced in defining and managing product development project activities to meet business objectives
• Learning
• Ability to rapidly learn and assimilate new technologies, technical material, and skills for operating new equipment and instrumentation

Administration

• Efficient in preparing high quality technical reports
• Knowledge of regulatory requirements as they may apply to new product development, e.g. ISO 9001 design controls, FDA GMP and HPB requirements

Processes and Theories

• Knowledge of design of experiments (DOE)
• Knowledge of techniques of stress analysis and failure criteria
• Theoretical understanding of flow-related phenomena of fluids in tubes
• Intermediate experience in computational fluid dynamics (CFD)
• Basic knowledge of aerosol delivery

Materials

• Knowledge of plastics including experience in the design of high-volume injection molded components and material selection.
• Knowledge of the properties of polymers, plastics and other materials used for external and indwelling medical applications
• Work Habits, Communication Skills, and Interpersonal Skills
• Ability to work independently
• Persuasive and skilled communicator
• Demonstrated creative problem solving through inventiveness and innovation
• Enjoy ‘raising the bar’ in design solutions’ ability to meet functional, manufacturing and cost objections
• Passion for developing design solutions and seeing them through to manufacturing launch

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

If you interested in this employment opportunity, please apply through LinkedIn