Our Customer is a highly regarded global medical devices company is searching for an R&D Mechanical Design Engineer to lead product development activities for a new electromechanical medical device platform. The R&D Mechanical Engineer will be responsible for mechanical life cycle engineering, from concept through launch, and post development support for new products, leading overall product design as well as component design.
Requirements for R&D Mechanical Engineer - Medical Devices:
- Bachelor's degree in Engineering, preferably mechanical engineering, advanced degree preferred
- 7+ years experience in design of complex mechatronic systems, Class II electro-medical devices.
- Working experience modeling with computer aided design software (Solidworks 2017 and higher): solid and surface modeling
- The ability to work with product development team members in Europe. A strong understanding of cross cultural, international product development strongly preferred
- Understanding of Product Data Management system (Solidworks PDM)
- Experience with reliability testing methods and principles.
- A working understanding of IOT
- Experience with tolerance stack-up analysis, static FEA and fatigue analysis.
- Knowledge of geometric dimensioning and tolerancing GD&T (ANSME Y14.5-2009)
- Knowledge of design control processes following ISO13485 or FDA 21 CFR 820 “Design Control Guidance For Medical Device Manufacturers”
The R&D Mechanical Engineer will:
- Design and develop mechanical parts and assemblies for a new medical device platform. This will include overall product design, as well as components of the device.
- Prepare / approve mechanical development documentation, including product requirements, design specifications, and verification and validation protocols
- Design 3D models and prepare design drawings and layouts for new products and components, such as cosmetic injection molded parts, structural and motorized assemblies, sheet metal components.
- Responsible to ensure that product development and design changes conform to the requirements of design control procedures.
- Work with R&D team members in the US as well as Europe.
- Provide technical support for new product manufacturing requirements.
- Manage project plans to meet established schedule and cost targets.
- Conduct / supervise verification and validation testing, and document testing results.
- Evaluate and implement improvements to product designs and manufacturing processes.
- Develop, review and approve engineering change orders, considering improvements to quality, cost, customer requirements.
- Develop, document and lead product and/or process pilot runs and validations for new products.Develop estimates for capital requirements to support products and prepare CER’s as necessary.
- Analyze, implement, and document design modifications required for improving product reliability.
- Participate in Risk Analysis and implement risk mitigations.