Job Description
SUMMARY/OBJECTIVE: The Senior Software Design Assurance Engineer is responsible for pre-market Design Quality Assurance related activities for the design and development of medical device software.
ESSENTIAL DUTIES AND RESPONSIBILITIES
[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.]
o Maintains compliance with design control activities per 21 CFR 820.30 and ISO 13485:2016.o Authors or provides input to design verification activities, including master verification planning, protocol development, data collection and analysis, and reporting.o Works with R&D for the creation of design input and output documents.o Performs software analysis, code review, SOUP assessment and anomaly reportingo Manages software configuration control during the design cycle and transfer to manufacturing.o Manages design review activities related to software.o Ensures product requirements traceability from user needs to design verification test reporting.o Works within the document control system to author, route, and approve controlled documents.o Collaborates with the Commercial team and R&D regarding Human Factors testing.o Works with R&D in the development and test of software testing tools and fixtureso Collaborates with R&D on software related risk management activities.
o Participates in third party and internal quality audits involving areas of responsibility. o Establishes, maintains Standard Operating Procedures and Forms related to areas of responsibility.o Advises and trains other Company personnel concerning areas of responsibility.o Communicates information related to quality management system effectiveness. o Works in accordance with quality system procedures. Other duties as assigned by Supervisor.