A key member of the product development team, the design engineer develops both new product design and design change, leading engineering tasks and support through to production. A focus on creative design solutions to meet product requirements using resources such as CAD tools and analysis techniques coupled with an understanding of materials, manufacturing processes, tool design and cost of production. A focus is to ensure technical documentation is completed to fulfill the requirements of the design history file, following established design controls to meet medical product regulatory compliance requirements.
Essential Job Functions:
To perform the job successfully, the individual must accomplish the following:
• Develop design solutions to meet defined product requirements.
• Lead engineering input through new product development and design change.
• Create, refine and manage complex 3D product solid models using SolidWorks.
• Produce detailed drawings for production specifications.
• Organize and maintain design data and digital records for design history files.
• Prepare technical documentation such as BOM, work instructions, test plans, test reports, risk analysis, labelling, product acceptance criteria and design reviews.
• Member of new product development teams and support release to production.
• Assembly of prototypes and production samples for verification and validation.
• Schedules work to meet completion dates.
• Bachelor of Science degree in Mechanical Engineering or related Engineering Technology degree. Minimum of an associate’s degree with related experience.
• Experience in CAD environment with preference of 3+ years’ experience in mechanical design.
• Creative and resourceful with an ability to apply design concepts through development to realize design into production.
• Product design experience and mechanical aptitude with a working knowledge of component manufacturing processes for both metals and plastics.
• Ability to develop and carry out testing to verify and validate designs.
• Ability to apply analytical techniques to design and risk analysis, such as DFMEA.
• High level 3D CAD knowledge, fully competent in use of SolidWorks.
• High level of drafting knowledge with proficiency in dimensioning and tolerance.
• Knowledge of MS Office and effective digital file management skills.
• Organized and detail oriented, with good technical writing skills.
• Team oriented, able to lead engineering effectively in a cross functional team environment.
• Standard working conditions include an office and manufacturing environment.
• Full-time, 40 hours/week Monday-Friday, with extended hours on occasion.
• May require lifting up to 40 pounds occasionally.
• Business travel required, less than 10%