Sr R&D Engineer

Menlo Park, CA | Contract

Post Date: 09/27/2017 Job ID: 3003 Industry: Software/Hardware

PURPOSE OF JOB: Use mechanical engineering and product development knowledge to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan.

 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Use product development knowledge to lead product through verification/validation.

  • Apply engineering knowledge to troubleshoot and solve product testing issues as needed.

  • Generate written reports.

  • Apply mechanical engineering knowledge to design processing/prototyping fixtures/tooling and testing fixtures.

  • Use Solidworks to generate CAD models and engineering drawings for new components, fixtures, and/or assemblies.

  • Use mechanical engineering knowledge to design, prototype, test new delivery systems such as advanced catheter design, deflectable shafts, ergonomic handle, etc.

  • Create test methods for component and product testing as needed.

  • Solve mechanical engineering problems at the component through system level.

  • Conduct testing utilizing existing test protocols or develop new ones as needed.

  • Assign work to technicians and temporary workers as needed.

  • Complete projects (including product enhancements) in a manner consistent with corporate objectives.

  • Contribute to the intellectual property position of the company via invention and patent applications.

  • 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.

  • Provide mechanical engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.

  • Oversee outside vendors and consultants as required.

  • Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.

  • Provide mechanical engineering support in the resolution of product complaints and/or safety issues.

  • 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.

 

 

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

EXPERIENCE REQUIREMENTS: 5-10 years of experience in the medical device industry.

Experience in delivery system or advanced catheter design. Experience in drug device combination products preferred.

OTHER QUALIFICATIONS: Ability to perform word processing and create basic spreadsheets. Proficiency in SolidWorks preferred.

Physical Activities and Requirements, Visual Acuity and Working Conditions:

  • Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.

  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

  • Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

 

 

 

 

 

 

 

 


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