Engineering Compliance and CSV Manager

Amboss Technologies Inc.

Job Overview

Location

Berlin

Job Type

Full-time

Full Job Description

📋 Description

• As CSV & Process Validation Manager, prove our systems and processes work and produce reliable evidence.
• Own the computer system validation and process validation processes for the AMBOSS medical device portfolio — procedures, templates and work instructions — keeping them aligned with MDR and ISO 13485 and updated based on audit findings and team feedback.
• Maintain the inventory of systems in scope and decide, risk-based, which need validation and to what depth; plan, execute and document that validation and keep systems in a validated state as they change.
• Concentrate validation effort where the evidence is produced — test management, defect tracking, build/release tooling and automated pipeline steps whose output can't be fully verified by inspection alone — confirming these systems and processes reliably produce trustworthy, intended results.
• Own the resulting evidence and represent it directly to auditors and regulators; raise, document and own validation deviations and the associated CAPAs through to resolution.
• As Engineering Compliance Manager, ensure the medical device product itself is built compliantly, from a day-to-day engineering work perspective
• Own compliant execution of the software lifecycle — requirements, design, implementation, verification, release — against IEC 62304 and IEC 82304-1
• Define the compliance requirements and gates in our delivery pipeline against IEC 62304 and IEC 82304-1 (traceability tagging, release criteria, automated checks) and partner with engineering to implement them.
• Operate the compliance gate in the release flow, keeping the trace intact from user requirement through verification to released evidence. Sign off each release as a required gate; no release ships without your approval.
• Ensure engineering-related Technical Documentation deliverables are compliant with regulatory and QMS requirements
• Onboard and train software engineers on compliance requirements and how to work within them day-to-day.
• Act as the point of contact for audits and technical reviews on engineering-related topics, representing the team's compliance posture to auditors and Notified Body reviewers.
• Drive resolution of audit findings and deficiencies affecting engineering.
• Assess the engineering impact of Design Changes before they are implemented.
• Identify and drive adoption of tooling the team is missing to work compliantly — both inside the QMS and on the engineering side.
• You will work closely with engineering as an independent evaluator, setting the standard for what 'done and compliant' means across our medical device software.
• You will join a small, high-impact team ensuring our medical device software meets the regulatory standards needed to safely support healthcare professionals.

🎯 Requirements

• Knowledge of medical devices or another regulated industry (pharma, biotech, IVD).
• Experience in, or eagerness to learn, computer system validation and/or process validation, including risk-based scoping of validation effort.
• Working knowledge of MDR, ISO 13485, IEC 62304 and IEC 82304-1 as they apply to software.
• Familiarity with software engineering, and enough depth in our stack (React, Python, PHP, Go; AWS, Terraform, Kubernetes, ArgoCD) to review pipelines, tests and release processes with engineers as a peer.
• Experience representing validation documentation and rationale to auditors and inspectors.
• Experience assessing the engineering/technical impact of Design Changes within a regulated development process.
• Excellent written and spoken English.

🏖️ Benefits

• Innovative work keeps employees energized, and employee benefits help them to feel appreciated and empowered.
• Employee benefits package, crafted to support financial, physical, and mental health and work-life harmony.
• Diversity is a powerful driver of innovation and progress, and AMBOSS is committed to fostering an inclusive, respectful, and supportive environment where everyone is valued and given equal opportunity to thrive.
• Even if you don't meet every single point in the job description, AMBOSS still encourages you to apply.

Skills & Technologies

Python

PHP

React

AWS

Kubernetes

Onsite

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Amboss Technologies Inc.

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About Amboss Technologies Inc.

Amboss Technologies operates the Amboss platform, a data analytics and intelligence network for the Bitcoin Lightning Network, providing real-time routing optimization, channel management tools, and market insights for node operators, merchants, and enterprises to improve liquidity, reduce payment failures, and enhance overall network efficiency.

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