Software Engineer - with a possible R&D Role

A small, innovative medical device manufacturer based in Tualatin, Oregon, is seeking a skilled Software Engineer to support ongoing development of embedded systems and PC-based applications for regulated medical devices. This is a technical leadership position with the potential to expand into Research & Development management over time, depending on the candidate’s interest and aptitude.

 

This role requires hands-on software development experience, strong documentation habits, and a commitment to working within a multidisciplinary engineering environment governed by international medical device regulations. Candidates who would be ideal are those with experience or interest in R&D leadership, such as design controls, cross-functional collaboration, and product development strategy.

 

Key Responsibilities: Software Engineering

·      Design, develop, and maintain embedded firmware and PC-based applications

·      Architect software systems and manage usability design aligned with human factors principles

·      Create and maintain comprehensive design documentation across the software lifecycle

·      Perform prototype development, pre-production verification, and release testing

·      Lead software Verification & Validation protocol creation and execution

·      Collaborate on design transfer activities and support audit-readiness

·      Participate in product design reviews and cross-functional development discussions

·      Learn and apply design control methodologies under ISO 13485, MDSAP, FDA 21 CFR, EU MDR, and applicable IEC standards

·      Assist with usability, safety, and risk assessments and systems-level testing

·      Contribute to risk management documentation and manufacturing handoff processes

·      Bachelor's degree in Engineering, Computer Science, or equivalent experience

·      Proven experience in embedded software development (C, C , Assembly)

·      Proficiency in desktop application development and software architecture

·      Familiarity with IDEs, debugging tools, and relational databases (SQL Server, MS Access)

·      Strong communication and technical documentation skills

·      Experience developing software within regulated medical device environments

·      Exposure to international quality systems (ISO 13485, FDA 21 CFR, EU MDR, IEC 62304)

·      Interest or experience in systems design, project leadership, or regulatory alignment

·      Ability to collaborate across hardware and mechanical engineering teams

·      Technical problem-solving and innovation

·      Lifecycle documentation and traceability standards

·      Usability and safety-critical design thinking

·      Cross-functional communication and collaboration

·      Ability to contribute beyond software scope if desired