Description
Sr. Mechanical Design EngineerRESPONSIBILITIES:
This position is responsible for, but not limited to, the following:
- High-quality execution and on-time achievement of product design, engineering feasibility and testing under regulated design controls
- Technical leadership of product development projects and teams
- Design and develop new, novel products and support existing products
- Create multiple concepts for complex problems, build representative prototypes (physical-prototypes and virtual-computer models), devise and perform tests to prove the concept and communicate results
- Highly skilled in modeling solids and surfaces using solid modeling software (SolidWorks)
- Demonstrate engineering expertise in evaluating and analyzing designs, able to determine design capabilities and margins against requirements and applies design trade-offs and constraints for design optimization
- Develop specifications, test methodologies and execute verification and validation testing
- Document results in reports and laboratory notebooks and engineering reports
- Prepare and present comprehensive design reviews demonstrating technical rigor and attention to details
- Interact and collaborate effectively with cross functional groups i.e. (Quality, Regulatory, Manufacturing, Marketing)
- Ensure designs meet and exceed product specifications, regulatory requirements and international standards.
- Contributes to the creation of and maintenance of mechanical engineering and product development group processes
- Grow and maintain technical knowledge current with advancing technologies related to product development of medical devices
Minimum Qualifications
- Requires a B.S. in Mechanical Engineering, M.S. is a plus.
- Requires ten years of engineering experience, including five years of medical device product development (ISO, GMP, FDA, CE). Advanced engineering degrees may be considered toward the minimum experience requirement.
- Proficient with solid modeling software (SolidWorks).
- Excellent written and verbal communication skills. Must be able to write clear technical descriptions of rationales, designs, observations, conclusions, and implementation instructions.
- Must perform well in cross functional teams.
- Ability to manage multiple tasks and projects.
To find out more about Real please visit www.realstaffing.com