Software Engineer

Software Engineer III

Job Summary: Talent Software Services is in search of a Software Engineer for a contract position in Gray, (near Portland, Maine), ME. The opportunity will be for one year with a strong chance for a long-term extension.

Position Summary: We are seeking a professional to drive the integration and migration of in-house software tools used for functional testing in manufacturing. The ideal candidate will bring strong technical expertise in C# development, along with a solid understanding of medical device manufacturing processes and related software systems. This individual should be able to work independently and proactively, demonstrating ownership, problem-solving, and collaboration skills to ensure a smooth and efficient transition across multiple applications and cross-functional teams.

Primary Responsibilities/Accountabilities:

• Review existing software tools for functional testing in manufacturing to determine compliance with Quality System requirements.
• Migrate software tools for functional testing from the existing manufacturing line in Irvine, CA to the new manufacturing site near Portland, ME.
• 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.

Qualifications:

• 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 working within or understanding 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.