Sr. Requirements Systems Engineer

Sr. Requirements Systems Engineer
Company:

Kforce Technology Staffing


Sr. Requirements Systems Engineer

Details of the offer

RESPONSIBILITIES:
Kforce has a client that is seeking a Senior Requirements Systems Engineer in San Francisco, CA.
Summary:
The Sr. Requirements Systems Engineer (Hardware/Software) is the interface between all of engineering disciplines to write both high level system requirements as well as lower level input requirements by working with individual engineers and others. The Sr. Requirements Systems Engineer (Hardware/Software) applies a multidisciplinary approach to ensure technical needs are translated into step-by-step processes. The Sr. Requirements Systems Engineer (Hardware/Software) works closely with all facets of engineering, as well as with the usability, regulatory, manufacturing, and quality functional areas to ensure alignment with cross functional teams to release documents in a timely manner. The Sr. Requirements Systems Engineer (Hardware/Software) is integral in compiling and documenting risk analysis information and creating the traceability matrix. The Sr. Requirements Systems Engineer (Hardware/Software) is the point person for ensuring documentation relating to engineering changes is reviewed, updated and finalized.
Essential job functions and duties:
* Create high level system requirements with input from the design teams
* Review, update and release documents written by the engineering team
* Compile input from multidisciplinary stakeholders and generate documentation outlining Risk Analysis based on ISO 14971 guidelines
* Write the system level V&V test plan and help the validation team with protocols and reports
* Work with engineers to create test protocols
* Create the traceability matrix
* Perform other duties as assigned
REQUIREMENTS:
* Bachelor's degree in Systems, Electrical, Computer, Biomedical or Mechanical Engineering and a minimum 5 years of related experience; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
* Experience in the medical device regulated industry based on ISO 13485
* Above average ability to relay technical information orally and write clear and concise documents for review by regulatory agencies
* Good documentation, recordkeeping and data collection skills with attention to detail
* Understanding of statistical sample size techniques to determine the appropriate amount of test samples
* Excellent teamwork and interpersonal skills
* Ability to work with minimal supervision
* Familiarity with automated PLM tools e.g. Polarion is a plus
Qualified candidates must be presently authorized to work in the United States on a full-time basis. This company does not sponsor or transfer H1-visa individuals.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.


Source: Dice


Area:

Requirements

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