Validation Engineer

Clinical ink; Søborg; On-site; 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

Company Information

Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.

Job Description

Clinical Ink is seeking a Validation Engineer to join Clinical Ink's Disease Management team based in Denmark and the United States. In this role, you will be a hands-on Validation Engineer who prepares, executes, and reports verification and validation (V&V) across all the software our QMS relies on. You will also evaluate and qualify our suppliers, and oversee a subset of AI agents. The Validation Engineer's responsibilities include but are not limited to:

• 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.

Qualifications

• 3+ years software/system V&V in a regulated environment (medical device, SaMD, digital health, or equivalent).
• Working command of ISO 13485 design V&V and/or IEC 62304.
• Hands-on protocol authoring, objective evidence, and traceability discipline.
• Comfort with risk-based, proportionate assurance and with supplier evaluation.
• Structured-content / "docs-as-code" ways of working; evidence-first integrity.
• Preferred experience: SaMD / digital health / observational-study technology, AI/ML validation, structured-content quality systems.

Additional Information

Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

www.clinicalink.com