Product-Driven MedTech Enterprise Architect

Vitrolife & Igenomix Brasil, part of Vitrolife Group; Göteborgs kommun; On-site; SEK 1,200,000 - 1,800,000; Full time

Job summary

Vitrolife Group is seeking an Enterprise Architect in Gothenburg to guide our shift from project-driven delivery to a domain-based product operating model in a MedTech setting with regulatory and AI governance considerations.

You will architect for empowered product teams, define domain boundaries, govern via ADRs, and ensure alignment to SaMD/regulatory standards while driving governance across delivery pipelines.

Qualifications

• Proven experience as an enterprise, solution, or lead architect in a product-operating-model or platform-engineering context.

Responsibilities

• Architect for empowered, autonomous product teams aligned to business domains, not a central control point.
• Own canonical domain and data models across the organization, including alignment to standards like FHIR R5 where relevant.
• Write and review architecture decision records (ADR/LDDR) as the primary governance mechanism.
• Define enforceable, auditable guardrails for agentic AI systems, aligned to the EU AI Act.
• Bring SaMD classification, ISO 14971, IEC 62304, and MDR/IVDR cybersecurity requirements into architecture decisions from the start.
• Champion Team Topologies, platform engineering, and governance-as-code across delivery pipelines.

Job description

Vitrolife Group is seeking an Enterprise Architect in Gothenburg to guide our shift from project-driven delivery to a domain-based product operating model in a MedTech setting with regulatory and AI governance considerations.

You will architect for empowered product teams, define domain boundaries, govern via ADRs, and ensure alignment to SaMD/regulatory standards while driving governance across delivery pipelines.