Staff Verification Engineer (Andover, MA)

Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Computer Science, Biomedical Engineering, or a related field., 6 years of experience in the Medical Device Industry for Bachelor's or 4 years for Master's., Experience with FDA regulations, ISO standards, and embedded systems design or testing., Proficiency in Python, MATLAB, LabVIEW, and test management tools like JIRA or Azure DevOps..

Key responsibilities:

  • Lead large scale projects’ test activities and align with Program Management.
  • Act as a Subject Matter Expert in test stands software automation and scripting.
  • Draft verification plans, protocols, and technical documentation for testing.
  • Plan and execute both manual and automated software testing for medical devices.

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Smith+Nephew XLarge http://www.smith-nephew.com/
10001 Employees
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Job description

Staff Verification Engineer, Smith & Nephew, Inc., Andover, MA:

Autonomously lead large scale projects’ test activities, allocate test equipment and materials and align with Program Management and multi-functional team work and timeline. Act as a Subject Matter Expert (SME) in leading and supporting test stands software automation and scripting. Identify, report, track, prioritize HW/SW defects using defects management systems (e.g. JIRA) and validate fixes. Support the Systems Engineers with definition of new products – implementing operational profiles, preparing for test, dry-run, executing test, tracing requirements to test cases and guiding the test strategy. Support trouble shooting and root causing of Systems defects and enable R&D team identify fixes. Draft verification plans, protocols, test cases, summary reports, trace matrix and other related technical documentation; Provide transparency to trace matrix test coverage and test progress for programs. Plan, develop and execute software testing (both manual and automated) for medical devices, based on context and risks associated with the project. 60% Telecommuting permitted within the MA state. 

Monday – Friday, 40 hours per week.

MINIMUM REQUIREMENTS:

Bachelor’s degree in Electrical Engineering, Computer Engineering, Computer Science, Biomedical Engineering or a related field and 6 years of post-baccalaureate work experience in the Medical Device Industry. Alternatively, the employer will accept a Master’s degree in Electrical Engineering, Computer Engineering, Computer Science, Biomedical Engineering or a related field and 4 years of work experience in the Medical Device Industry.

Education and experience may be, but need not be, gained concurrently.

Of the required experience, must have 4 years of experience in all of the following:

  • Medical device industry, where one of the following is applied: Food & Drug Administration (FDA), Good Manufacturing Practice, FDA 21 Code Federal Regulation (CFR) Part 820, or 
    ISO (International Standards Organization) 13485:2016.
  • Embedded systems (combining microprocessors or microcontroller) design or test experience.

Of the required experience, must have 3 years of experience in all of the following:

  • Test revision control management solution experience such as: Jama, Cockpit, Azure DevOps or Helix/TestTrack. 
  • Identify, troubleshoot, and validate fixes for hardware or software failures.
  • Drive or support requirements creation and review for systems design inputs and sub-system requirements.
  • Test Development involving test planning, authoring, executing, and reporting.

Of the required experience, must have 2 years of experience in all of the following:

  • Python Test Development.
  • MATLAB or LabVIEW test development or data analysis.
  • Visual Studio Development or Test Automation.
  • Software Code Analysis and unit test tools (LDRA, SonarQube, VectorCast, Ceedling, or similar).
  • Requirement and Test Management tools (Helix, DevOps, DOORS, or similar).
  • Bugs tracking tools (JIRA, Bugzilla, or similar).
  • Digital circuits, microprocessor hardware, and software (work experience or graduate-level educational course work acceptable).
  • Test experience with at least one of the interface communications buses: CAN (Controller Area Network), RS232 (Recommended 232), USB (Universal Serial Bus), I2C (Inter-integrated 
    Circuit), SPI (Serial Peripheral Interface), or PCIe (Peripheral Component Interconnect Express).

Of the required experience, must have 1 year of experience in all of the following: 

  • Failure Mode & Effects Analysis for medical device systems and sub-components. 
  • EMC Test Plan and Test Setup Development.


Agile Scrum Certified.

This position is eligible for our employee referral program. A copy of the company’s ERP is available for reference here: https://tinyurl.com/4aebs4dh

To refer someone for this job, please please follow the candidate referral tutorial, in order to submit your referral through Workday: https://tinyurl.com/2mstyu3f

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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Required profile

Experience

Spoken language(s):
English
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Other Skills

  • Troubleshooting (Problem Solving)
  • Problem Reporting

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