Job Title - Medical Device Test Engineer

Job Location - North Haven, Connecticut (Fully Onsite)

Type: W2 Contract

Skills Required:

Software testing

Software validation

Technical writing and communication

Develop testing strategies for non-production software.

Draft validation plans, protocols, and reports.

Routing documents for approval in Agile.

As a Software Test Validation Engineer, you will use your broad understanding of software validation techniques for medical or other regulated systems. You will develop a strong understanding of the SW architecture, design, and execute the test strategy, perform release activities of Software tests in compliance with regulatory standards.

Must-Have: Minimum Requirements

Bachelor’s degree required

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have:

Knowledge of Medical Product verification, IEC-62304, and FDA guidance.

Understanding of creating test protocols for verifying software requirements.

Strong understanding of good documentation practices.

Ability to work with QA to ensure testing meets Quality and Regulatory needs.

Ability to manage, track, and upgrade multiple hardware and software configurations.

Ability to work with Systems, Mechanical, Electrical, and Software engineers when

discovering, documenting, and resolving integration issues.

Familiarity with common programming languages such as C , C#, and Python is preferred.

Experience using a tool or repository for managing test cases (GIT Stash, JIRA, etc).