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Biomedical R&D Engineer
Ref No.: 17-06963
Location: Andover, Massachusetts
Position Type:Contract
Start Date: 11/06/2017
Job Category:Non-IT Engineering

  • This role will support the Systems Engineering function within the Advanced Diabetes Care (ADC) R&D organization for development of a new product platform for the Diabetes Care market.
  • The successful candidate will assure the quality of Systems Engineering deliverables and the timely delivery of a system meeting customer needs, business objectives and strategic goals.
  • The Systems Engineer will serve as an Engineering representative on development projects with specialized focus on Failure Analysis and other R&D development and related root cause efforts within the ADC organization.
  • Perform testing for system level Failure Analysis efforts.
  • Collect and organize test data.
  • Effectively communicate test results.
  • Investigate failures to determine Root Cause.
  • Collaborate with R&D to propose solutions for failure mitigation.
  • Analyze complex electromechanical product designs.
  • Select appropriate analytical equipment and develop techniques for analysis of new and existing technologies.
  • Coordinate with outside labs as needed to accomplish FA when equipment needed is not available in-house.
  • Apply technical standards, principles, theories, concepts and techniques to design products and systems.
  • Actively support quality engineers and R&D during risk management activities.
  • Use statistics to analyze, summarize, and communicate test results and data.
  • Provide clear and concise documentation of results and publish reports.
  • Maintain the FA lab as an orderly and safe work area.

  • High School Diploma/GED (Required).
  • Bachelors Dergree - B.S in Systems Engineering, Biomedical Engineering, Physics, Mechanical Engineering or similar (Required).
  • Masters Degree (Preferred).

  • B.S in Systems Engineering, Biomedical Engineering, Physics, Mechanical Engineering or similar.
  • 1-3 years relevant work experience or a combination of equivalent education and experience.
  • Medical product development or other highly regulated environments highly preferred (ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes is a plus).
  • Structured development and engineering processes (emphasis on systems engineering) and methodologies such as DFSS (Design for Six Sigma).
  • Experience in root cause analysis, six sigma methodologies a plus (utilizing tools such as Fault Tree, Failure Mode and Effects Analysis and Safety Assurance Case methodology).
  • Experience conducting DOEs, IQ/OQ/PQ or Verification & Validation (V&V) activities.
  • Knowledge and understanding of complex electromechanical systems, fluidic systems a plus.
  • Ability to work with engineering and other professionals in a cross-functional matrix organization.
  • Ability to work independently, as a key problem solver and interact with internal and external stakeholders.
  • Excellent written and verbal communication skills and ability to present ideas and results effectively.
  • Strong self-management, prioritizing and multi-tasking skills to work within tight deadlines Team player with the ability to work independently and a results-oriented 'can-do' attitude.