Medical Engineering Consultants (MEC) ยท 18 hours ago
Software Engineer III
Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to enhance productivity. They are seeking a Software Engineer III to drive the integration and migration of software tools used for functional testing in manufacturing, requiring strong technical expertise in C# and knowledge of medical device manufacturing processes.
ConsultingMedical DevicePharmaceuticalTraining
Responsibilities
Review existing software tools for functional testing in manufacturing to determine compliance with the Client's Quality System requirements
Migrate software tools for functional testing from existing manufacturing line to new manufacturing site
Work with manufacturing engineers to validate test equipment software and assist in identifying test strategies where necessary
Collaborate with cross-functional teams including manufacturing engineers systems engineers quality RD and PMO
Contribute to a culture of innovation continuous improvement and knowledge sharing within the RD team
Qualification
Required
Bachelor's or master's degree in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major
Minimum 4 years of experience in software development or testing for medical device manufacturing
Engineering background with strong knowledge of manufacturing processes and systems
Familiarity in C# development particularly for manufacturing-related applications
Familiarity with functional testing processes within manufacturing settings
Ability to collaborate cross-functionally with manufacturing quality and RD teams
High ability to make knowledge-driven decisions and work with little supervision
Excellent documentation and communication skills for technical and process alignment
Strong problem-solving and analytical skills applied to production or testing workflows
Preferred
Experience working within or understanding client's manufacturing procedures and standards
Experience in active implantable medical devices
Proven ability to manage or execute software migration projects for in-house manufacturing software tools
Knowledge of ISO 13485 and FDA QSR
Working knowledge of IEC 60601 and/or 62304
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.