Job Description

CSV Engineer
PCD320185

Sweden / Europe
Regulatory & QA – Quality /Full-time /Remote

About the Role

At the organisation, we develop innovative medical technologies that enhance healthcare outcomes. As a Computer System Validation Engineer, you will execute validation activities for software tools and computer systems used across engineering, manufacturing, operations, and quality. You will ensure validation activities are planned, executed, and documented in compliance with medical device regulations, maintaining validated state for systems in scope while supporting business continuity and audit readiness.
More than just ticking compliance boxes, you'll champion a "quality beyond compliance" mindset that transforms validation activities into genuine business value. Your work will directly contribute to the company's success by ensuring our systems are not only compliant but also optimized for performance and efficiency, while helping to shape our future by innovating and developing our quality processes.

About the organisation

Distributed and Remote First
We are nearly 100 full time engineers at the company, working from Berlin, Chamonix, Hamburg, Lisbon, Marseille, Vilnius, and Stockholm, spanning diverse disciplines such as Hardware Engineering, Firmware Development, Electrical Design, Algorithm Development, Machine Learning Development, Optronics Research, Frontend Development and more. We don't expect people to join us with a specific tech knowledge, but we do expect you to work with our tools. We use a mix of React, Typescript, C++, and Python. Our APIs are written in C# with ASP.NET Core, uses public cloud platform Cosmos DB, and cloud identity platform for authentication.

Our headquarters and our hardware development team are in Stockholm, Sweden.

We are a Remote First company; however, it is of course much easier to work remotely as a software engineer than a hardware or firmware engineer (since they require access to hardware or devices occasionally). Software engineers based in Stockholm work maybe one day a week or one day every two weeks from the office.

We meet a couple of times per year to get to know each other and have fun.

Organization and Way of Working.
the organisation is divided into smaller cross-functional project teams that each focus on a specific goal or target, where some groups are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We strive to create groups which are cross-functional and able to complete their goals without dependence on other teams, even though this is of course not always possible.

Groups track goals on a yearly and quarterly basis with goal follow-up across the entire engineering organization on a bi-weekly basis. Most groups do internal planning on a bi-weekly basis, but in the end it's up to the group to decide how they want to work.

We have, however, mandated that all groups must present their progress or failures or hacks at our bi-weekly engineering demo, a fun meeting/presentation where we talk about everything from short-circuiting power-modules, how hard it is to calibrate cameras or align polygons in space, to neat new command line tools for operations, a new auth mechanism in the backend, a cool new way to visualize health data or a new feature which helps our doctors be more productive.

We have a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Responsibilities:
Plan and execute validation activities for new and existing computer systems across all departments.
Develop and execute validation protocols, test cases, and traceability matrices for software tools and systems under scope.
Prepare and maintain audit-ready validation documentation, including validation plans, protocols, reports, and supporting evidence.
Conduct risk assessments and determine appropriate validation strategies based on system criticality and complexity.
Coordinate validation activities with cross-functional teams including IT, Quality, Engineering, and Operations.
Follow established validation processes and guidelines to ensure consistent, risk-based validation.
Support validation of both purchased and internally-developed tools, including scripts, automation, and QMS-integrated solutions.
Identify, document, and escalate validation issues, deviations, or risks in accordance with procedures.
Support internal and external audits by providing validation evidence and addressing auditor requests.
Provide feedback and suggestions to improve validation templates, processes, and tooling to reduce manual effort.
Collaborate with system owners, IT, engineering, and quality stakeholders to ensure validation activities align with business needs.

Requirements:
5+ years of experience in computer system validation, software validation, or similar roles within the medical device, regulated, or life sciences industries.
BSc or MSc in Computer Science, Engineering, Systems, or related technical discipline.
Experience validating both commercially-purchased systems and internally-developed software (including scripts and automation).
Working knowledge of regulatory requirements for system validation, including EU MDR (2017/745 Annex XI) and US FDA (21 CFR Part 820 and Part 11).
Practical experience with CSV principles, risk-based validation approaches, and frameworks such as GxP, GAMP, and ISO/TR 80002-2.
Experience working in agile development environments and applying iterative validation approaches that balance compliance with development velocity.
Skilled at writing and executing validation protocols, test cases, and reports.
Experience maintaining audit-ready documentation and supporting audit requests.
Strong analytical and problem-solving skills with attention to detail.
Excellent written and verbal communication skills in English.
Nice to Have:
Experience with cloud-based systems and SaaS validation in regulated environments.
Hands-on experience with CI/CD platform and similar DevOps tools for validation workflow management and automation.
Knowledge of automated testing tools and DevOps practices applied to validation.
Familiarity with data integrity principles and practices (ALCOA+ principles).
Active participation in professional organizations such as ISPE.
Experience with agile validation approaches and CI/CD pipelines.