Sr. Engineer, Carlsbad, CA
The Sr. Engineer will be responsible for development and manufacturing of cardiovascular products from a technical standpoint. This includes identifying design criteria and approach, design and selection of components, testing of new and existing device concepts, design, development and validation of manufacturing processes including equipment, operational and process qualifications, 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;
- Designs components and mechanical assemblies using Solidworks or other software and creates product documentation including drawings, BOMs, and specifications;
- Designs, develops, and qualifies new manufacturing processes. This includes feasibility studies, designing and implementing evaluations (DOE’s), Equipment Qualification, Operational and Process Qualification (OQ/PQ) and Test Method Validation
- Author technical documents including Process and Test Method Validation Protocols and Reports
- Analyze results of process capability studies
- Provides technical support analyzing, performing and documenting failure analysis (FMEA) for discrepant production components, assemblies and field returns (i.e NCR’s and CAPAs).
- Develops specifications for materials, and works with outside suppliers;
- 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, Manufacturing or both
- Experience with manufacturing and 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 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 arms.
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 20 pounds.
The noise level in the work environment is usually low to moderate.