InOffice Not Remote Software Engineer and RD Manager

Benefits401(k) matchingBonus based on performanceCompetitive salaryDental insuranceHealth insurancePaid time offTraining & developmentVision insuranceWellness resourcesOverviewA 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.ResponsibilitiesDesign, develop, and maintain embedded firmware and PC-based applicationsArchitect software systems and manage usability design aligned with human factors principlesCreate and maintain comprehensive design documentation across the software lifecyclePerform prototype development, pre-production verification, and release testingLead software Verification & Validation protocol creation and executionCollaborate on design transfer activities and support audit-readinessR&D Leadership (Optional Contribution Area)Participate in product design reviews and cross-functional development discussionsLearn and apply design control methodologies under ISO 13485, MDSAP, FDA 21 CFR, EU MDR, and applicable IEC standardsAssist with usability, safety, and risk assessments and systems-level testingContribute to risk management documentation and manufacturing handoff processesQualificationsRequiredBachelor's degree in Engineering, Computer Science, or equivalent experienceProven experience in embedded software development (C, C++, Assembly)Proficiency in desktop application development and software architectureFamiliarity with IDEs, debugging tools, and relational databases (SQL Server, MS Access)Strong communication and technical documentation skillsPreferredExperience developing software within regulated medical device environmentsExposure to international quality systems (ISO 13485, FDA 21 CFR, EU MDR, IEC 62304)Interest or experience in systems design, project leadership, or regulatory alignmentAbility to collaborate across hardware and mechanical engineering teamsKey CompetenciesTechnical problem-solving and innovationLifecycle documentation and traceability standardsUsability and safety-critical design thinkingCross-functional communication and collaboration #J-18808-Ljbffr

Created: 2025-09-30