Staff Quality Engineer
MedAcuity, LLC

Job Order #: 20196433

Westford, MA 01886

Full Time

40 hours per week

POSTED 12/27/2023

EXPIRES 3/26/2024

Job Description

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 the project schedule. The incumbent will be exposed to software risk assessments, the implementation of test strategies, and potentially the participation 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.

-    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 as well as 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, including: manual as well as black box test protocols, simple to
     moderately complex user interface testing that supports a number of different platforms, and
     tests that utilize more sophisticated approaches such as scenario-based testing in addition to
     structured exploratory testing.
-    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.
-    Generate defect reports and verification of correct technical fixes.
-    Develop an understanding of complete SDLC phases, especially IEC 62304.
-    Perform other duties as may be required.

-    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.
-    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 SDLC working closely with developers during feature
     development and testing phases.
-    Excellent attention to detail and strong organizational skills.
-    Strong communication skills including written, verbal, and listening.

-    Exposure and experience working with the requirements of FDA QSRs, ISO 13485, IEC 62304,
     IEC 60601 and ISO1497.
-    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 a related discipline is preferred, but will also consider
     candidates with equivalent years of production experience.

How To Apply

Please submit your resume to for consideration.


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