Software Design Assurance Engineer (Medical Devices)

Groupe Kardol; Oregon City (OR); Vor Ort; USD 62.000 - 103.000; Vollzeit

Benefits dieser Stelle

Benefits program

Growth opportunities

Learning programs

Zusammenfassung

Dexcom, a leader in continuous glucose monitoring, is seeking a Software Design Assurance Engineer to ensure conformance to software development processes and quality standards. You will interface with cross-functional teams to lead lifecycle processes, drive risk management, and support post-market activities, contributing to safe, effective medical device software.

Typical qualifications include a technical bachelor's degree and 0–2 years of related experience, with a preference for strong

Qualifikationen

• Medical device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485.
• SDLC knowledge and software development methodologies (Agile, Waterfall).
• Experience in requirements analysis, design/development, integration and testing.
• Ability to communicate with all levels of management.

Aufgaben

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Lead in the effective application and improvement of software development and validation policies.
• Drive pre-market risk deliverables like SHA, design FMEA and support cybersecurity risk management.
• Provide guidance to Software design and test teams, support configuration management and tool validations.
• Review and approve all software design control deliverables.
• Support post-market activities related to software anomalies, risk assessments and CAPA.

Kenntnisse

FDA 21 CFR Part 820

IEC 62304

SDLC

Agile / Waterfall

Ausbildung

Bachelor’s degree in a technical discipline

Jobbeschreibung

Dexcom, a leader in continuous glucose monitoring, is seeking a Software Design Assurance Engineer to ensure conformance to software development processes and quality standards. You will interface with cross-functional teams to lead lifecycle processes, drive risk management, and support post-market activities, contributing to safe, effective medical device software.

Typical qualifications include a technical bachelor's degree and 0–2 years of related experience, with a preference for strong