Sr. R&D/Mechanical Engineer, Carlsbad, CA
The Sr. R&D Engineer will be responsible for development of cardiovascular products from both a technical and program management standpoint. This includes 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 PRO/E or other software and creates product documentation including drawings, BOMs, and specifications;
- 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; and
- Identify and manage product improvements, for example: cost reduction or efficiency improvements.
- All other duties as assigned
- Bachelor’s Degree in Engineering and/or equivalent discipline;
- 7+ years relevant work experience;
- Experience with class II/III medical device R&D and/or Manufacturing;
- Experience with design/development of coronary stents, stent delivery systems, and balloon catheters;
- Experience with drug eluting stents, abluminal drug coating, and biodegradable polymer is preferred;
- 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.
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 may be exposed to hazardous materials. Physical demands include, but are not limited to: hearing, writing, standing, sitting, walking, and speaking. Duties of this position may produce a high level of mental and visual fatigue. Mental demands include, but are not limited to: reading, detailed work, confidentiality, problem solving, verbal and written communication, constant interruptions, math and stress.
Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus.
The employee must occasionally lift and/or move office products and supplies, up to 35 pounds.
The noise level in the work environment is usually low to moderate.