Principal Software Automation Test Engineer – Medical Devices

Responsibilities

• Evaluate requirements for quality and completeness to ensure they meet user needs.
• Develop test methods for verification.
• Lead automated test strategy and implementation.
• Reduce overall test burden through structured automation of existing and new testing.
• Plan and implement automation using Lab View, Test Complete, and similar utilities.
• Design standalone automation applications for specialized functionality.
• Use AI tools for developing testing, automation, and documentation.
• Test advanced image reconstruction and processing algorithms.
• Participate in all phases of product development: reviewing requirements, design, usability, risk assessment, and defects.
• Identify and catalog software defects in assigned functional areas; assist in triage, investigation, and resolution.
• Identify plans and execute test process improvements to continually enhance performance.
• Generate test protocols based on product requirements and project needs.
• Set up and use physical imaging phantoms.
• Document and report test results; communicate and present findings effectively.
• Collaborate and maintain excellent working relationships with team members and stakeholders.
• Perform all activities in compliance with the Quality System, environmental, health and safety regulations.

• Minimum requirements:
  • BS degree in a related engineering discipline (software, biomedical, etc.).
  • Minimum 8 years of relevant experience.
  • For baccalaureate degrees earned outside the United States, the degree must satisfy 8C.F.R. §214.2(h)(4)(iii)(A).
• Nice to have:
  • Ability to handle multiple tasks/projects.
  • Experience with Agile and iterative development practices.
  • Experience in regulated environments.
  • Understanding of federal and international medical device regulations: FDA QSR, ISO
    14971, ISO
    62304, ISO
    13485, and EUMDR.
  • Experience with Lab View or Test Complete.
  • Excellent interpersonal, written, and verbal communication skills.
  • Strong time‑management and organizational skills.

Regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers.

Sponsorship is offered exclusively for Principal‑level roles and above. Positions below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

We are an equal employment opportunity employer and provide reasonable accommodations for qualified individuals with disabilities. We do not discriminate on the basis of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity or expression, genetic information, marital status, or any other characteristic protected by federal, state, or local law.