Software Engineer (Manufacturing)

Advantage Technical; Maine; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading technology firm in Maine is seeking an experienced software engineer to lead the integration and migration of functional testing software tools used in manufacturing operations. Ideal candidates will have a background in C# development and a solid understanding of medical device manufacturing processes. Responsibilities include reviewing existing software for compliance, leading migration efforts, and collaborating with cross-functional teams. Candidates should have at least 4 years of experience in software development or testing, along with strong problem-solving skills.

Qualifications

• Minimum 4 years of experience in software development or testing within medical device manufacturing.
• Strong engineering background with knowledge of manufacturing processes and systems.
• Excellent documentation and communication skills for technical and process alignment.

Responsibilities

• Review existing functional‑testing software tools for compliance with quality system requirements.
• Lead migration of software from current manufacturing line to new site.
• Collaborate with engineers to validate test equipment software.

Skills

C# development

Problem-solving

Collaboration

Documentation

Analytical skills

Education

B.S. or M.S. in Computer Science, Electrical Engineering, or related field

Job description

This role focuses on leading the integration and migration of in‑house software tools used for functional testing within manufacturing operations. The ideal candidate brings strong C# development expertise and a solid understanding of medical device manufacturing processes and supporting software systems. Success in this role requires independence, proactive problem‑solving, and effective collaboration across multiple applications and cross‑functional teams.

Key Responsibilities

• Review existing functional‑testing software tools to ensure compliance with Boston Scientific Quality System requirements
• Lead the migration of functional‑testing software from the current manufacturing line in Irvine, CA to the new manufacturing site near Portland, ME
• Partner with manufacturing engineers to validate test equipment software and support development of test strategies
• Collaborate with cross‑functional teams including manufacturing engineering, systems engineering, quality, R&D, and PMO
• Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team

Required Qualifications

• B.S. or M.S. in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or related field
• Minimum 4 years of experience in software development or testing within medical device manufacturing
• Strong engineering background with knowledge of manufacturing processes and systems
• Proficiency in C# development, particularly for manufacturing‑related applications
• Familiarity with functional‑testing processes in manufacturing environments
• Ability to collaborate effectively with manufacturing, quality, and R&D teams
• Strong decision‑making skills with the ability to work independently
• Excellent documentation and communication skills for technical and process alignment
• Strong analytical and problem‑solving abilities applied to production or testing workflows

Preferred Qualifications

• Experience with or understanding of Med Device manufacturing procedures and standards
• Background in active implantable medical devices
• Demonstrated ability to manage or execute software migration projects for in‑house manufacturing tools
• Knowledge of ISO 13485 and FDA Quality System Regulation (QSR)
• Working knowledge of IEC 60601 and/or IEC 62304