Requirements and Verification Engineer (m/f/d) Digital Health

BAYOOMED; Berlin, Darmstadt, München; Hybrid; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

BAYOONET Group in Berlin is seeking a Requirements and Verification Engineer (m/f/d) for Digital Health to coordinate V&V activities across medical software projects. You will ensure traceability from requirements to test cases and act as a bridge between development, QA and customers.

The role requires knowledge of IEC 62304, ISO 13485, MDR, and experience with test automation. A hybrid work setup includes on-site and remote work, with travel to DACH as needed.

Qualifikationen

• Degree in medical technology, computer science, natural sciences or equivalent.
• Knowledge of requirements engineering and tools like Jira, Microsoft DevOps.
• Curiosity for AI-supported technologies and automated processes.
• Experience in the verification & validation of medical or safety-critical software incl. corresponding strategies and documentation.
• Initial experience in test automation using various frameworks and test suites is an advantage.
• Familiarity with regulatory requirements such as IEC 62304, ISO 14971, ISO 13485, MDR.
• Structured, independent way of working, strong communication skills, analytical thinking and high attention to detail.
• Willingness to undertake occasional business trips in the DACH region for customer workshops and selective on-site support.
• Excellent German and English language skills.

Aufgaben

• Coordinate and carry out verification and validation activities – in accordance with IEC 62304, ISO 13485, MDR and customer-specific requirements.
• Accompany requirements throughout their entire life cycle – from elicitation and consolidation to the derivation of test cases.
• Ensure clear traceability throughout the V-model between requirements at different levels and to test cases.
• Act as an interface between development, QA and customers – and incorporate V&V requirements into project planning at an early stage.
• You will be involved in reviews, design verifications and acceptance tests.
• You support the creation and maintenance of technical documentation and audits/inspections.

Kenntnisse

Requirements engineering

V&V for medical software

Test automation

Regulatory knowledge

German & English

Ausbildung

Degree in medical technology / CS

Tools

Jira

Microsoft DevOps

Jobbeschreibung

Requirements and Verification Engineer (m/f/d) Digital Health

You coordinate verification and validation activities for medical software projects in accordance with IEC 62304, ISO 13485 and MDR, ensure traceability in the V-model and act as an interface between development, QA and customers.

Requirements and Verification Engineer (m/f/d) Digital Health

We are strongest when we work together as a team—that’s why we operate a hybrid model with at least three days per week on-site at the respective location and two days working flexibly from home.

• You coordinate and carry out verification and validation activities – in accordance with IEC 62304, ISO 13485, MDR and customer-specific requirements.
• You accompany requirements throughout their entire life cycle – from elicitation and consolidation to the derivation of test cases.
• You ensure clear traceability throughout the V-model between requirements at different levels and to test cases.
• You act as an interface between development, QA and customers – and incorporate V&V requirements into project planning at an early stage.
• You will be involved in reviews, design verifications and acceptance tests.
• You support the creation and maintenance of technical documentation and audits/inspections.

Your profile

• A degree in medical technology, computer science, natural sciences or a comparable qualification
• Knowledge of requirements engineering and common tools (e.g. Jira, Microsoft DevOps, etc.)
• Curiosity and openness for AI-supported technologies and automated processes
• Experience in the verification & validation of medical or safety-critical software incl. corresponding strategies and documentation
• Initial experience in test automation using various frameworks and test suites is an advantage
• Familiarity with regulatory requirements such as IEC 62304, ISO 14971, ISO 13485, MDR
• Structured, independent way of working, strong communication skills, analytical thinking and high attention to detail
• Willingness to undertake occasional business trips in the DACH region for customer workshops and selective on-site support.
• Excellent German and English language skills

Here’s what you can expect

Diverse teams of co-thinkers and customers who work together collaboratively and as equals

A positive error culture – we celebrate successes and continuously improve our collaboration

BAYOONIVERSITY for experience exchange, training, tech talks and company events

Growing vacation quota with company affiliation

Bright offices, themed meeting rooms, fresh fruit, coffee and cold drinks

Opportunities to actively contribute to exciting and challenging tasks and projects

Flexible work hours and models where no work hours are lost (lifetime work account)

Performance-based pay plus the option of a company pension plan

Locations with excellent public transportation and highway access

Flat hierarchies in cross-functional teams

About us

The BAYOONET Group, with locations in Darmstadt, Berlin, Munich, Cologne, Ludwigsburg, Höhn, Basel and Mannheim, has been designing customized software and hardware in a wide range of variants for over 25 years. We are one of the top IT companies in Germany and consist of:

Each of our projects incorporates the ideas, visions, creative contributions, and technical expertise of every team member, which makes all the difference.