Systems Engineer

Lake Forest  ‐ Onsite
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Keywords

Description

Essential Duties and Responsibilities
  • Support all levels of requirements development including the development and implementation of performance, regulatory, manufacturing, labeling, and other requirements.
  • Responsible for administration and management of requirements databases, risk databases, and traceability matrices using DOORs software.
  • Support planning, execution, and reporting of ongoing risk management activities including DFMEA and PFMEA.
  • Support configuration management of a large portfolio of medical products
  • As part of larger projects, performs routine engineering assignments including product development process and change package quality documentation using good documentation practices (GDP).
  • May write experimental, verification, and validation protocols and reports. May also develop and maintain records of testing and analysis performed.
  • Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
  • Other duties as assigned.


Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Experience with medical product requirements development and management. Significant experience with DOORs software is strongly preferred.
  • Good written and verbal communication skills
  • Ability to work as a collaborative team member.
  • Strong attention to detail
  • Ability to simplify and articulate complex and/or ambiguous requests into concise specifications.
  • Ability to prioritize and manage multiple task assignments with minimal supervision
  • Ability to solve routine design and engineering tasks including product design documentation with some assistance. Able to solve problems with periodic monitoring.
  • Ability to discuss normally encountered technical or process issues, both verbally and in written form.
  • Background and/or Experience:
  • B.S.in Engineering and at least 2 years relevant experience. MS in engineering, medical product development, configuration management, and DOORs experience strongly preferred.


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
Duration
8 Months
From
Real Staffing
Published at
08.04.2014
Project ID:
691257
Contract type
Freelance
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