Senior Software Design Assurance | DHF Remediation Expert

GlobalLogic; Poland; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Learning & Development support

Relocation and rotation options

Inclusive workplace

Comprehensive benefits

Job summary

GlobalLogic is seeking a Senior Software Design Assurance / DHF Remediation Engineer for a Medical Device project. You will lead DHF completeness and ensure compliance with FDA, IEC, and ISO standards, acting as the DHF documentation gatekeeper.

You will manage, assess, and remediate software lifecycle documents, review V&V protocols, and support audits in a regulated environment. Strong cross-functional collaboration is essential.

Qualifications

• 8+ years in Software Design Assurance, Quality Engineering, or Regulatory Affairs in Medical Devices.
• Strong knowledge of FDA 21 CFR 820.30, IEC 62304, ISO 13485.
• Hands-on DHF remediation, gap analyses, and legacy compliance updates.
• V&V review expertise: protocols, test reports, and anomaly logs.
• Attention to detail and cross-document consistency.
• Collaborates with software architects, requirements engineers, and SMEs.

Responsibilities

• DHF completeness & assessment: gap analyses against QMS and regulatory requirements.
• Lifecycle documentation support: draft/review SDP, CM Plan, and release docs.
• V&V oversight: review planning, test protocols, and summaries.
• Design review facilitation: document records, close actions, justify phases.
• Anomaly management: log, assess risk, and trace to mitigations.
• Audit readiness: package remediated DHF for regulatory audits.

Skills

DHF remediation

V&V experience

Regulatory awareness

Cross-functional collaboration

Audit readiness

Job description

GlobalLogic is seeking a Senior Software Design Assurance / DHF Remediation Engineer for a Medical Device project. You will lead DHF completeness and ensure compliance with FDA, IEC, and ISO standards, acting as the DHF documentation gatekeeper.

You will manage, assess, and remediate software lifecycle documents, review V&V protocols, and support audits in a regulated environment. Strong cross-functional collaboration is essential.