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Sr. R&D Engineer

PostId 906c4a61-2604-4a33-a6f0-926b373aad3d
Posted Date: 4/16/2010
Job Category: R&D
Salary Range: DOE
Location: Bay Area (South Bay)
Description: Position Title: Sr. Research and Development Engineer
Reports to: Vice President of R&D
Department: R&D
FLSA Status: Exempt
Company: Private

JOB DESCRIPTION: This position is responsible for the concept and design development of innovative medical devices. You will use your mechanical engineering and product development experience to design devices, device components and device subsystems in support of the company’s strategic plan. You will play a significant role in new product development, “next generation” planning and development and work closely with surgeons and marketing group to analyze, define, and meet customer needs. You will both manage and perform mechanical design functions and use your medical materials technology to develop complex designs for novel surgical or in office products.

MAJOR DUTIES AND RESPONSIBILITIES:

• Apply mechanical engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
• Design and detail new products using Solidworks, or other 3d CAD package.
• Perform Finite Element Analysis (FEA) on components and systems.
• Evaluate mechanical fit of plastic parts and components, conduct tolerance and stack up analysis, and verify function from component to system level.
• Familiarity and experience in design of bioabsorbable materials a huge plus.
• Solve mechanical engineering problems at the component through system level.
• Conduct testing utilizing existing test protocols or develop new ones as needed.
• Generate written protocols and reports that meet company and regulatory agency requirements.
• Complete projects (including product enhancements) in a manner consistent with corporate objectives.
• Excels at documenting new ideas and development of intellectual property.
• 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.
• Oversee outside vendors and consultants as required.
• Work with other engineering, manufacturing clinical affairs, sales and marketing, and quality assurance staff to coordinate pilot production of new products. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Contributes to the definition of processes for the manufacture of new and existing product.
• Participates in the preparation of detailed design documentation, design testing and prototype fabrication.
• Basic machine shop knowledge.
• Excellent oral and written communication skills.
• Proficiency in FDA Regulations: QSR and cGMP


EDUCATION REQUIREMENTS: BSME, BSE Materials Engineering, BSE Biomedical Engineering or equivalent.


EXPERIENCE REQUIREMENTS: Minimum of 5-years of experience in the medical device industry.