Software Engineer with a possible RD Role

Benefits: 401(k) matching Bonus based on performance Competitive salary Dental insurance Health insurance Paid time off Training & development Vision insurance Wellness resources 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 candidates 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 R&D Leadership (Optional Contribution Area) 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 Qualifications: Required 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 Preferred 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 Key Competencies 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

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