Staff II Quality Engineer

Westford, MA /
Engineering /
Are you a Quality Engineer? Then, take the next step in your career, develop new skills, and collaborate with an outstanding team!
 
At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop software-driven medical devices, robotic technology, embedded systems, and computer vision solutions. 
 
We seek a passionate and experienced Staff Quality Engineer who is interested in playing a key role in the cutting edge MedTech space.  the Staff Quality Engineer will participate in the testing of software throughout the product development lifecycle of medical devices. This position will work from requirements to create test cases and execute the tests per project schedule. Will be exposed to software risk assessments, will implement test strategies and may participate in software risk assessments. 
 
Together, we’re pioneering the future of science by developing Software products and solutions that enable our partner teams to help save lives.

RESPONSIBILITIES

    • Participate in requirements analysis and determine if a requirement is testable. Read through system requirements and develop an understanding of basic functionality. Generate and maintain simple trace matrices.
    • Support risk management activities to ensure basic software risk control measures are identified and verified
    • Analyze architecture and designs to identify test points
    • Facilitate/participate in documentation and tracking of verification activities. Report test results and contribute to test reports, with supervision.
    • Follow established test methodologies and acceptance criteria, using good technical writing skills, to design and implement:
    • Manual, black box test protocols
    • Simple to moderately complex user interface testing that supports a number of different platforms and tests that utilize more  complex approaches such as scenario-based testing, structured exploratory testing
    • Cross platform testing that deals with multiple kinds of browsers or mobile device platforms or embedded platforms.
    • Advanced database testing (CRUD) that performs moderately complex queries to get or set data.
    • Develop and execute basic acceptance, performance, load, system-level and reliability types of testing with guidance, using test equipment such as emulators or simulators or measuring equipment as needed
    • Perform data analysis, and investigations into test results
    • Generate defect reports and verification of correct technical fixes
    • Develop an understanding of complete software development lifecycle phases, especially IEC 62304.
    • Provide reasonable estimates of own assignments to complete work, considering traceability and prioritization of work
    • Embody company values in work performance, decision making and, in all interactions
    • Perform other duties as may be required
    • Abide by and ensure compliance with MedAcuity’s policies, including Information
    • Security and Quality Management Systems

QUALIFICATIONS

    • 5+ years of experience with relevant and recent experience performing the same or similar type of work as required by the position.
    • Hands-on experience with defect tracking and metrics.
    • Exposure and experience working with the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO1497.
    • Excellent attention to detail and strong organizational skills.
    • Strong communication skills including written, verbal and listening.
    • Proficient computer skills with applicable software packages (e.g. Microsoft Office, MatLab, Excel, etc.)
    • Expertise with requirements management software such as Helix ALM, Jama, or Doors.
    • Experience in a team-oriented traditional Waterfall or fast-paced Agile development processes, working closely with developers during feature development and testing phases.

PREFERRED SKILLS

    • Comprehension of the value which automated test tools offer for continuous integration.
    • Ideal to have exposure and / or experience working with Class 3 medical device verification and validation experience or equivalent.
    • A solid understanding of design control and defect analysis in accordance with industry standards and regulations.
    • Prior involvement with risk assessments, test strategy definition, and implementation.
    • BS degree in Computer Science or related discipline is preferred, but will also consider candidates with equivalent years of production experience.
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.