ECI · 2 weeks ago
Software Test/Validation Engineer (Med Device) #0583
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
4+ years expECI is a global leader in professional consulting services for the life sciences industry, seeking a senior-level engineer to enhance their software tools for functional testing in manufacturing. The role involves reviewing and migrating software tools, collaborating with cross-functional teams, and contributing to a culture of innovation within the R&D team.
BiotechnologyConsultingLife ScienceProject Management
No H1B
Hiring Manager
Brittney Cowens
Responsibilities
Review existing software tools for functional testing in manufacturing to determine compliance with Quality System requirements
Migrate software tools for functional testing from existing manufacturing line to new line
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, R&D, and PMO
Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team
Qualification
Required
B.S or M.S 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 R&D 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 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
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase