Senior Quality Engineer

Westford, MA /
Engineering /
Full Time
At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop custom software for their next-generation software-driven medical devices and solutions. We are looking for a Senior Software Quality Engineer who wants to apply their exceptional technical skillset and problem-solving acumen to develop innovative, secure, safe and reliable software to support the product development needs of our MedTech clients. 

This role provides overall leadership in the testing of software throughout the product development lifecycle. Will own projects, define test strategies, and develop and coordinate verification and validation plans. As a “go-to” professional, drives analysis and refines requirements for testability, gaps and clarity.

Qualifications

    • 8+ years’ experience in quality testing
    • BS Degree, Computer Science or Computer Engineering preferred
    • Strong working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971 
    • Expertise with defect tracking and metrics
    • Strong technical writing skills, including development of test methods, protocols, reports 
    • Hands-on experience using automated testing tools for continuous integration
    • Experience with Class 3 medical device verification and validation
    • Knowledge of requirements management software such as Helix, ALM, Jama or Doors
    • Proficient computer skills including the Microsoft Office Suite and MatLab
    • Builds partnership and works collaboratively to meet objectives
    • Eagerness to mentor and share knowledge 
Applicants for employment at Medacuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.

MedAcuity is an equal opportunity employer.