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Software Design Quality Engineer

Spectraforce Technologies
United States, Massachusetts, Westford
Apr 09, 2026
Position Title: Software Design Quality Engineer Work Location: Westford, MA, USA, 1886 Assignment Duration: 12 months Work Arrangement: Onsite What You'll Do Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA) Support on-time execution of Quality Plans Guide development and documentation of standard operating procedures, specifications and test procedures Support product recertifications CAPA management - including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria. Work within Agile software development lifecycle framework Support usability and human factors engineering reviews Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection Review and approve test methods, protocols and test results provided by another functional group. Support activities related to software change management and overall change management Support all activities, as needed by the business within the software development lifecycle. Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps Support internal & external audit and related responses Support the establishment of objective, measurable and verifiable customer and product requirements Complete document Change Request reviews in a timely and objective manner Additional duties may be identified by functional management based on the current project/business objectives. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Perform other related duties and responsibilities, on occasion, as assigned. Requirements EDUCATION AND EXPERIENCE YOU'LL BRING Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience. Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality Experience ensuring automation frameworks and scripts meet design control requirements Experience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama Experience as team-member/lead in Agile SDLC projects/programs Deep knowledge of various types of SDLC's (V-Model, Iterative, Agile/Scrum, etc.) Experience working in a broader enterprise/cross-site business unit model Working knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485 Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment Ability to work in a lab, and hands-on experience with medical device development Ability to leverage and/or engage others to accomplish projects Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Ability to multitask, prioritize and meet deadlines in timely manner Strong organizational and follow-up skills, as well as attention to detail Master's level degree preferred ASQ CSQE and ISTQB certifications desired Experience working with test management tools such TestComplete, desired Experience in code review/static analysis tool(s) to aide code review such as Coverity, desired Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired Clinical/Hospital experience desired Experience in software testing and verification/validation, desired.