Remote Software Design QA Engineer - Growth & Impact

RXinsider LTD.; San Diego (CA); Hybrid; USD 79,000 - 132,000; Full time

Benefits offered by this job

Comprehensive benefits program

Growth opportunities

Tuition reimbursement

Career development

Job summary

Dexcom Corporation seeks a Software Design Assurance Engineer to ensure conformance to software development processes and global safety standards. You will collaborate with Software Engineering, Regulatory, Marketing, and Cybersecurity to improve product quality and safety.

You will drive pre-market risk management, review design history files, support validation, and communicate status to leadership in a fast-paced environment. FDA 21 CFR Part 820 and SDLC knowledge are required.

Qualifications

• You have Medical Device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485.
• Knowledge of SDLC processes and methodologies (Agile, Waterfall, etc.).
• Experience in Software Quality or Engineering: Requirements Analysis, Design/Development, Product Integration and Test.

Responsibilities

• Act as core team member of the R&D Quality Assurance Engineering team.
• Guide on IEC 62304, 21 CFR 820, and global regulatory standards.
• Drive pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management.
• Review and approve all software design control deliverables.
• Support post-market activities related to software anomalies, risk assessments and CAPA.
• Lead and support R&D SW Design Assurance efforts including continuous improvement.
• Review, author, and revise design history files, SOPs, protocols and reports.

Skills

Medical Device Compliance

SDLC / Methodologies

Software Quality / Engineering

Requirements Analysis

Design / Development / Test

Cloud-based Systems

Communication & Presentation

Education

Bachelor's degree in a technical discipline

Master's degree (optional)

Job description

Dexcom Corporation seeks a Software Design Assurance Engineer to ensure conformance to software development processes and global safety standards. You will collaborate with Software Engineering, Regulatory, Marketing, and Cybersecurity to improve product quality and safety.

You will drive pre-market risk management, review design history files, support validation, and communicate status to leadership in a fast-paced environment. FDA 21 CFR Part 820 and SDLC knowledge are required.