Senior R&D Engineer

East Bay, (none selected) | Direct Hire

Post Date: 07/20/2016 Job ID: 3032 Industry: Consumer Electronics
  • 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.
  • Solve mechanical engineering problems at the component through system level.
  • Conduct testing utilizing existing test protocols or develop new ones as needed.
  • Generate written reports.
  • 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.

OTHER QUALIFICATIONS:  Ability to perform word processing and create basic spreadsheets.

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).

 Equal Opportunity Employer


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