PRINCIPAL R&D ENGINEER (closed)
PRINCIPAL R&D ENGINEER
Simply Biotech specializes in recruiting exclusively for the biotech and medical device community. We are currently seeking a Principal Research and Development Engineer for a leading and growing Orange County medical device firm. Relocation assistance is available.
The qualified Principal R&D Engineer will be responsible for developing and designing novel based medical devices. The selected candidate will generate catheter design concepts, prototype builds, pre-clinical evaluations, and transfer of product to manufacturing. This person will further apply Mechanical Engineering knowledge to the design and development of new products. The Principal R&D Engineer will:
* Solve Mechanical Engineering problems at the component through system level.
* Develop, maintain and execute R&D project plans and coordinate cross functional team developmental activities in support of company's strategic plan.
* Develop test methods and procedures to evaluate device prototype performances.
* Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports.
* Maintain accurate documentation of concepts, designs, drawings, and processes.
* Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
* Assign work to technicians and temporary workers as needed.
* Interface with manufacturing, clinical affairs, quality, sales and marketing, outside consultants and vendors to ensure compliance with internal and external policies and procedures, QSR and FDA regulations and ISO standards.
The qualified Principal R&D Engineer will possess:
* A bachelor's degree in engineering is required; Electrical, Mechanical, Manufacturing or Biomedical Engineering preferred. MS a plus.
* 8+ years? relevant engineering experience
* 4+ years? experience with catheters; catheter experience, design, manufacturing, and process development
* Knowledge and experience with catheter product development from design to product launch, implants a plus.
* Knowledge of device Design Control, Quality Systems, documentation
* Good communication skills, written and verbal
* Experience working in cross functional teams and independent contributor role
* Experience developing test plans, and in-vitro / in-vivo testing
* Experience with CAD and/or solid modeling a plus in programs such as Pro-E, SolidWorks
* Experience with extrusions, materials, braided shafts, articulating designs, varied french sizes, etc.
* Experience with nitinol, cobalt chromium, and stainless steel materials a plus
**Relocation assistance is available.