Senior Software Design Assurance - DHF Compliance Engineer

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

Benefits offered by this job

Empowering Projects

Empowering Growth

DE&I Matters

Career Development

Comprehensive Benefits

Flexible Opportunities

Job summary

GlobalLogic is partnering with a US Med Device manufacturer to execute a comprehensive Design History File (DHF) remediation project for legacy medical device software. We are building a specialized compliance and documentation team to ensure that existing life-saving diagnostics software strictly adheres to FDA and international regulatory standards.

We are seeking a highly experienced Software Design Assurance / Quality Engineer to drive overall DHF completeness and compliance, acting as the

Qualifications

• 8+ years of experience in Software Design Assurance, Quality Engineering, or Regulatory Affairs within the Medical Device industry.
• Deep working knowledge of FDA Design Controls (21 CFR Part 820.30), IEC 62304, and ISO 13485.
• Hands‑on experience executing DHF remediation programs, retrospective gap analyses, and legacy compliance updates.
• Strong background in reviewing and approving software verification and validation protocols, test reports, and anomaly logs.
• Exceptional attention to detail with the ability to cross‑reference multiple compliance documents for consistency and completeness.
• Strong interpersonal skills to collaborate with software architects, requirements engineers, and technical SMEs in a regulated environment.

Responsibilities

• DHF Completeness & Assessment: Conduct comprehensive gap analyses of the existing Software Design History File (DHF) against internal QMS procedures and regulatory requirements.
• Lifecycle Documentation Support: Draft, review, and remediate SDP, Configuration Management Plan, and Software Release documentation.
• V&V Oversight: Support and review Verification & Validation planning, test protocols, and summary documentation for rigorous traceability.
• Design Review Facilitation: Ensure formal design review records are documented, actions closed, and historical design phases justified.
• Anomaly Management: Oversee anomaly and defect documentation, risk‑assessed and traced to mitigations.
• Audit Readiness: Package remediated DHF deliverables for regulatory audits.

Skills

DHF remediation

Regulatory mastery

V&V experience

Analytical rigor

Communication

Software Design Assurance

Job description

GlobalLogic is partnering with a US Med Device manufacturer to execute a comprehensive Design History File (DHF) remediation project for legacy medical device software. We are building a specialized compliance and documentation team to ensure that existing life-saving diagnostics software strictly adheres to FDA and international regulatory standards.

We are seeking a highly experienced Software Design Assurance / Quality Engineer to drive overall DHF completeness and compliance, acting as the