Software Validation Engineer in Andover, MA at Johnson Service Group

Date Posted: 10/16/2019

Job Snapshot

Job Description

JobID: 375392

Our client a world leader in the manufacturing of medical devices and safety diagnostics equipment located in Massachusetts whose offering a competitive salary and benefits is seeking for direct hire an experienced Software Validation Engineer to play a key role in their expanding business.

This individual will verification activities for C&D projects by testing, documenting and troubleshooting observed deviations. Execute and analyze verification test specifications to determine whether systems have met product requirements.  Identification and documentation of deviations.  Participate in Agile development project teams working towards common feature objectives.

  • Participate in an Agile software development environment working as part of a cross-functional sprint team to develop verification specifications, perform testing and generate test reports
  • Identify/document product deviations related to system requirements and record test methods/equipment used for reproducibility.
  • Participate in cross-functional meetings for product requirements, hazard analysis, and design reviews.
  • Contribute to the overall verification strategy and planning efforts as a member of a product feature team working closely with Verification leads.
  • Review and provide input to technical system requirements for testability of the product. 
  • Test risk-based software and hardware design mitigations contributing to the assurance of patient safety based on product hazards descriptions.
  • Provide input into completion of product traceability analysis from system requirements through product risk mappings in relation to verification specifications
  • Ensure compliance to all internal SOPs and FDA/industry regulations.
  • Assist in training and knowledge sharing for areas of expertise with other colleagues.
  • Perform other duties as required

Your Qualifications

Education: BS in relevant engineering discipline (e.g. Biomedical, Electrical, Computer, or Software Engineering).

Related Experience: 2-5 years of experience in verification/testing of products. Medical device experience preferred

Special Competencies or Certifications:

  • Proficient with the use of MS Office Products (Word, Excel, PowerPoint, SharePoint).
  • Prior working knowledge in a regulated industry with 510K submissions
  • Familiar with FDA, IEC, ISO regulations in relation to verification principles and patient monitoring.
  • Familiarity with JIRA, Rational ClearQuest/DOORs, LabVIEW, or Quality Manager a plus,
  • Ability to create robust documentation and having a strong attention to detail.

JSG is a leading staffing agency specializing in a variety of industries. Having been named to three Staffing Industry Analysts (SIA) lists for the third year in a row, JSG continues to grow and offer hiring solutions to companies across the United States and Canada. 

Contact:Rich Hanson