Validation Engineer (SaMD) — AI & QMS Focus

Clinical ink; Søborg; Hybrid; DKK 600,000 - 900,000; Full time

Job summary

Clinical Ink is seeking a hands-on Validation Engineer to join the Disease Management team, based in Denmark and the United States. You will perform V&V across the software underpinning the QMS, qualify suppliers, and oversee AI agents within a regulated environment.

Responsibilities include risk-based V&V, shift-left testing, automated traceability, and evidence packaging for release sign-off. The role calls for strong documentation discipline and supplier evaluation experience.

Qualifications

• 3+ years software/system V&V in a regulated environment (medical device, SaMD, digital health, or equivalent).
• Working knowledge of ISO 13485 design V&V and/or IEC 62304.
• Hands-on protocol authoring, objective evidence, and traceability discipline.

Responsibilities

• Plan and execute risk-based, least-burdensome V&V; scale rigor to intended-use risk.
• Shift left: rely on and accept adequate lower-level test evidence rather than re-executing it.
• Keep traceability automated and in continuous control.
• Qualify and keep the toolchain, infrastructure, and internal systems in a controlled state.
• Evaluate, qualify, and monitor suppliers; recommend approval.
• Compile release evidence packages for authority sign-off.

Skills

Software V&V

Regulated environment

ISO 13485

IEC 62304

Docs-as-code

Supplier evaluation

Job description

Clinical Ink is seeking a hands-on Validation Engineer to join the Disease Management team, based in Denmark and the United States. You will perform V&V across the software underpinning the QMS, qualify suppliers, and oversee AI agents within a regulated environment.

Responsibilities include risk-based V&V, shift-left testing, automated traceability, and evidence packaging for release sign-off. The role calls for strong documentation discipline and supplier evaluation experience.