Digital Health Requirements & Verification Engineer

bayoonet Aktiengesellschaft; Kentucky; Remote; USD 75,000 - 95,000; Full time

Job summary

bayoonet Aktiengesellschaft is seeking a Requirements and Verification Engineer (m/f/d) in Digital Health within Ohio, USA. You will coordinate verification and validation activities while ensuring compliance with regulatory requirements such as IEC 62304 and ISO 13485.

The ideal candidate should hold a degree in medical technology, computer science, or a related field, possess knowledge of tools like Jira and Microsoft DevOps, and have strong communication skills in both German and English.

Qualifications

• Degree in medical technology, computer science, or a comparable qualification.
• Knowledge of requirements engineering and tools like Jira and Microsoft DevOps.
• Experience in verification and validation of medical software including documentation.
• Excellent German and English language skills.

Responsibilities

• Coordinate verification and validation activities according to standards.
• Enable traceability between requirements and test cases.
• Act as an interface between development, QA, and clients.

Skills

Requirements engineering

Test automation

Communication skills

Analytical thinking

Education

Degree in medical technology, computer science, or natural sciences

Tools

Jira

Microsoft DevOps

Job description

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 together as a team – that’s why we work in a hybrid model with at least three days a week on site at the respective location and two days flexibly remotely.

• 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

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

Active participation opportunities in exciting and challenging tasks and projects

Flexible working hours and models where no working hours are forfeited (lifetime working time account)

Performance-related pay plus the option of a company pension scheme

Locations with excellent public transport and highway connections

Flat hierarchies in cross-functional teams

Thinkers wanted

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 achievements and professional expertise of every single contributor, which makes all the difference.