Senior R&D Mechanical Engineer

Description

Job Summary
The mechanical engineer (ME) is responsible for supporting the design, testing, production and improvement of devices. The ME will provide technical input and assure processes and work output are in compliance with FDA regulations and corporate strategies.

The duties and responsibilities included in this posting are intended to describe the general nature and level of the work to be performed in this position, but should not be interpreted as an exhaustive list of all responsibilities, duties and skills that might be required. All personnel may be required to perform duties outside of their normal responsibilities as needed.

Duties
- Assist lead engineers in ongoing production of clinical device products, including ordering materials, incoming inspection of raw materials, inventory management, and outsourced assembly
- Execute clinical product verification and validation testing and document findings in test reports
- Make recommendations for improvements; evaluate and make design changes as necessary
- Using SolidWorks, design and develop new components to improve clinical trial devices
- Create solid models and part drawings
- Build prototypes and coordinate the manufacture of components
- Participate in design reviews and support compliance to design control and design input requirements
- Prepare and compile device documentation for regulatory submissions
- Stay up to date on changing processes, procedures and regulatory requirements
- Assemble devices and components for product development testing and internal/external studies
- Research vendors and available manufacturing technologies
- Respond to changing needs of the organization
- Assist in miscellaneous tasks as assigned by lead engineers

Requirements

Qualifications
- B.S. in Engineering (mechanical, biomedical, or similar)
- 5+ years related technical experience - orthopedics/implantable is a plus!
- Experience in medical device product development and applicable regulatory (e.g., FDA) requirements
- Experience with hand tools and basic machining operations
- SolidWorks or equivalent CAD experience
- Experience with MS office; Word, Excel and Power Point
- Ability to understand and interpret engineering drawings, flow charts and manufacturing procedures
- Quick learner with the ability to keep up with changing processes and regulatory requirements
- Effective verbal and written communication skills
- Detail oriented, well organized
- Self starter with the ability to take direction and complete tasks in a timely manner

KEYWORDS: Medical device or R&D or research and development or product development or mechanical engineer or ortho or orthopedics or san diego or carlsbad, class III, implantables

To find out more about Real please visit www.realstaffing.com