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In-Office, Not Remote, Software Engineer and R&D Manager Job Opening In Tualatin – Now Hiring Sigmastim Domestic LLC


Job description

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
 


Required Skill Profession

Computer Occupations


  • Job Details

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