Software Design Assurance Engineer – Medical Devices

Groupe Kardol; Oregon; On-site; USD 62,000 - 103,000; Full time

Benefits offered by this job

Comprehensive benefits

Career growth opportunities

Tuition reimbursement

Job summary

Dexcom is seeking a Software Design Assurance Engineer to ensure conformance to software development processes and safety standards. You will interface with cross-functional teams to guide design, validation, and risk management across software activities.

The role emphasizes regulatory compliance, continuous improvement, and collaboration with Software Engineering, Regulatory Affairs, and Cybersecurity to deliver high-quality CGM solutions.

Qualifications

• Medical device experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Familiarity with SDLC and software development methodologies (Agile/Waterfall)
• Experience in software design assurance, risk management, and regulatory compliance systems

Responsibilities

• Act as a core team member of the R&D Quality Assurance Engineering team
• Provide guidance on IEC 62304, 21 CFR 820, and applicable worldwide regulations
• Lead application and continuous improvement of software development and validation policies
• Drive pre-market risk management deliverables like SHA and design FMEA
• Support post-market activities including risk assessments and CAPA
• Review and approve software design control deliverables
• Communicate plans and status to Dexcom leadership

Skills

Medical Device experience

FDA 21 CFR Part 820

IEC 62304

Quality Assurance

SDLC

Education

Bachelor's degree in a technical discipline

Tools

Cloud platforms

Regulatory documentation tools

Job description

Dexcom is seeking a Software Design Assurance Engineer to ensure conformance to software development processes and safety standards. You will interface with cross-functional teams to guide design, validation, and risk management across software activities.

The role emphasizes regulatory compliance, continuous improvement, and collaboration with Software Engineering, Regulatory Affairs, and Cybersecurity to deliver high-quality CGM solutions.