Advantage Technical · 19 hours ago
Software Engineer
Advantage Technical is seeking a Software Engineer – Manufacturing to support the integration, migration, and validation of in-house software tools used for functional testing within a medical device manufacturing environment. The role focuses on manufacturing test software and requires strong hands-on experience in developing and supporting C#-based applications in production and test environments.
Responsibilities
Review existing manufacturing functional test software to ensure compliance with Boston Scientific Quality System requirements
Migrate functional test software from the current manufacturing line in Irvine, CA to a new manufacturing site near Portland, ME
Collaborate with manufacturing engineers to validate test equipment software and define test strategies as needed
Support software validation activities, including documentation, troubleshooting, and process improvements
Partner cross-functionally with Manufacturing Engineering, Systems Engineering, Quality, R&D, and PMO teams
Contribute to a culture of innovation, continuous improvement, and knowledge sharing
Qualification
Required
Bachelor's or Master's degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, or related field
4+ years of experience in software development or test software support within medical device manufacturing
Strong understanding of manufacturing processes, systems, and production test environments
Hands-on experience developing C# / C+ applications for manufacturing or test systems
Experience supporting functional testing processes in a regulated manufacturing environment
Ability to work independently with minimal supervision and make data-driven decisions
Strong documentation, communication, and cross-functional collaboration skills
Proven analytical and problem-solving abilities applied to production or test workflows
Preferred
Experience working within Boston Scientific manufacturing procedures and standards
Experience supporting active implantable medical devices
Demonstrated success migrating or modernizing in-house manufacturing software tools
Knowledge of ISO 13485 and FDA Quality System Regulations (QSR)
Working knowledge of IEC 60601 and/or IEC 62304
Background in software test systems within high-volume or regulated manufacturing environments
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
Funding
Current Stage
Late StageCompany data provided by crunchbase