Senior Software Design Assurance Engineer — Impact CGM

Regulatory Jobs; San Diego (CA); On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Benefits program

Growth opportunities

Tuition reimbursement

Job summary

Dexcom Corporation is seeking a Senior Software Design Assurance Engineer to provide technical support and guidance to software teams for conformance to safety and quality standards (IEC 62304, ISO 13485, ISO 14971). This role interfaces with cross-functional groups and emphasizes defect prevention, product improvement, and compliance across software development and validation.

Responsibilities include leading risk management deliverables, guiding software design and test teams, and reviewing

Qualifications

• Medical Device experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Experience with SDLC processes and methodologies such as Agile and Waterfall
• Software Quality/Engineering across requirements, design, integration and test
• Ability to interpret software design and code to verify requirements
• Experience with cloud-based systems

Responsibilities

• Actively participates as a core member of the R&D Quality Assurance Engineering team
• Provide guidance on IEC 62304, 21 CFR 820, and global regulations
• Lead application and continuous improvement of processes for software development and validation
• Drive pre-market risk management deliverables and support cyber security risk management
• Review and approve software design control deliverables and support post-market activities

Skills

IEC 62304

FDA 21 CFR 820

SDLC

Agile / Waterfall

Cloud-based systems

Education

Bachelor’s degree in a technical discipline

Master’s degree in related field

Job description

Dexcom Corporation is seeking a Senior Software Design Assurance Engineer to provide technical support and guidance to software teams for conformance to safety and quality standards (IEC 62304, ISO 13485, ISO 14971). This role interfaces with cross-functional groups and emphasizes defect prevention, product improvement, and compliance across software development and validation.

Responsibilities include leading risk management deliverables, guiding software design and test teams, and reviewing