Software Engineer; Manufacturing
Job in
Presque Isle, Aroostook County, Maine, 04769, USA
Listed on 2026-02-12
Listing for:
Advantage Technical
Full Time
position Listed on 2026-02-12
Job specializations:
-
Manufacturing / Production
Manufacturing Engineer, Medical Device Industry, Validation Engineer -
Engineering
Manufacturing Engineer, Medical Device Industry, Validation Engineer
Job Description & How to Apply Below
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
- 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
- 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
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