Our client is an award-winning product development firm who focuses on bringing medical devices from first concept to market launch. We are looking for a Mechanical Engineer who is highly creative and can execute and occasionally lead mechanical design, and development activities through all phases of the medical product development process.
- Execute the design and development of complex electro-mechanical medical devices and equipment
- Use strong conceptual skills and abilities to build functional prototypes and develop detail CAD design packages (3D data and 2D drawings)
- Maintain day-to-day communication with program managers and all appropriate program team members
- Research and procure sample components and develop high-functioning design prototypes
- Bachelor’s degree in Mechanical Engineering with 3-5 years of relevant experience
- Experience and a high degree of competence in the design of complex medical capital equipment, and disposable devices is required.
- Familiarity with appropriate FDA, QSR and ISO regulations: design controls, regulatory approval methods, and overall medical device industry knowledge is preferred
- Possesses a high level of experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, etc.
- Expert level skill in SolidWorks and/or ProEngineer, with additional experience with GD&T and general dimensioning best practices
- Familiarity with FMEA, DFMA techniques, BOM structuring, test protocol writing, verification testing, quality inspection methodology, and report writing