As a temporary R&D Software Design Control Specialist, you will support the development and maintenance of medical device software used in cancer diagnostics. Based in Glostrup, this hybrid role involves close collaboration with cross-functional teams to uphold design control standards throughout the software lifecycle.
Key Responsibilities
- Implement software design control processes in alignment with the organization’s Quality Management System
- Ensure pathology software solutions meet applicable regulatory requirements
- Support the creation and maintenance of Design History File (DHF) documentation
- Translate user needs into clear product requirements and user stories
- Perform software and cybersecurity risk analyses to support product safety and effectiveness
- Work with test and validation teams to verify and validate software designs
- Engage with stakeholders across Marketing, Procurement, Regulatory Affairs, Quality, Manufacturing, Development, and Global Service
Qualifications
Applicants should hold a university degree in IT, Computer Science, Software Engineering, or a Life Science discipline. A solid background in software development and product sustaining is essential, particularly within regulated industries such as medical devices or pharmaceuticals.
Proven experience in design control practices—including requirements management, verification and validation, change control, risk assessment, and defect tracking—is required. Familiarity with IVD (In Vitro Diagnostic) software development is a strong advantage.
Preferred candidates will have knowledge of medical device standards such as IEC 62304 and ISO 14971, as well as experience working in Agile development environments.
Work Environment
This position operates in a hybrid model, allowing up to two days of remote work per week. The team values structured, systematic workflows and thrives in complex, evolving environments. Collaboration and clear communication are central to success.
Compensation and Benefits
- Individual bonus plan
- Private health care and medical insurance
- Life insurance coverage
- Company pension scheme
- Career development opportunities within a global organization
The company is committed to equal opportunity employment and welcomes applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
