Mechanical Engineer – Carlsbad, CA
The Mechanical Engineer will be responsible for development of new innovative medical devices from both a technical and program management standpoint. This may include identifying design criteria and approach, design and selection of components, development of operating characteristics, testing of new and existing device concepts, and development and testing of new processes and/or assembly methods for prototype, clinical, and production devices.
Duties and responsibilities
- Provides design solutions by completing design analysis and calculations, evaluating options
- Develops appropriate device performance characteristics through an understanding of clinical need
- Gathers input from internal and external sources for innovation and continuous improvement of devices and general engineering operations
- Designs prototypes as well as tests and troubleshoots initial device concepts
- Develops specifications for materials, and works with outside suppliers
- Develops test equipment and processes to demonstrate product performance characteristics
- Designs components and mechanical assemblies using Solidworks or other software and creates product documentation including drawings, BOMs, and specifications
- Manufacturing support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures
- Support validation of product, equipment and processes
- Interface with other departments to solve manufacturing production problems
- Investigation and testing of product processes.
- Actively participates in pre- and post-production troubleshooting of design problems
- Designs for manufacturing in a GMP environment
- Keeps abreast of latest technology, materials, processes, for use in job related areas
- Identify and manage product improvements, for example: cost reduction or efficiency improvements
- Bachelor’s Degree in Engineering and/or equivalent discipline
- 2+ years relevant work experience/7+ years relevant work experience for Sr. Mechanical Engineer
- Experience with class II/III medical device R&D and/or Manufacturing
- Experience with design/development of stents, stent delivery systems, and balloon catheters
- Familiarity with ISO 13485, 21 CFR Part 820 QSR, and Medical Device Directives (MDD)
- Knowledge and familiarity with mechanical and electronic manufacturing and test equipment
- Good writing and communication skills
- Works well in a team environment
- Solid modeling experience (i.e. PRO/E, SolidWorks)
- Finite Element Modeling & Analysis experience (i.e. ABAQUS)
The physical demands described here are representative of those that must be met by an employee
to successfully perform the essential functions of this position.
While performing the duties of this position, the employee is regularly required to talk or hear. The
employee frequently is required to use hands or fingers, handle or feel objects. The employee is
regularly required to stand; walk; sit; use hands and fingers, handle or feel: and reach with hands and
Specific vision abilities required by this position include close vision, distance vision, and the ability to
The employee must occasionally lift and/or move office products and supplies, up to 20 pounds.
The noise level in the work environment is usually low to moderate.