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 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

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