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Job Details

InOffice Not Remote Software Engineer and RD Manager

  2025-10-14     SigmaStim Domestic LLC     Tualatin,OR  
Description:

Benefits

  • 401(k) matching
  • Bonus based on performance
  • Competitive salary
  • Dental insurance
  • Health insurance
  • Paid time off
  • Training & development
  • Vision insurance
  • Wellness resources

Overview

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.

Responsibilities

  • 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
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