R&D Software Design Control Specialist (Medical Devices, Glostrup)

Job summary

This role involves contributing to the Research & Development of software for medical devices, specifically focusing on pathology staining instruments for cancer diagnostics. The position is temporary and allows for partial remote work.

Qualifications

• Engineering degree in IT/Computer/Software or Life Sciences preferred.
• Experience in software product development and maintenance.
• Familiarity with design control processes, including requirements engineering and risk management in a regulated environment (e.g., medical devices or pharmaceuticals).
• Strong English communication skills.
• Knowledge of medical standards such as IEC 62304 and ISO 14971 is a plus.
• Experience with Agile software development is preferred.

Responsibilities

• Execute software design control activities in line with quality management systems.
• Ensure compliance of software products with regulatory requirements.
• Contribute to product documentation and user requirements analysis.
• Conduct risk assessments for software safety and effectiveness.
• Collaborate with various stakeholders, including marketing, regulatory affairs, and quality assurance teams.

Skills

• Strong organizational and communication skills.
• Ability to manage multiple priorities and deadlines.
• Systematic approach to problem-solving in complex environments.

Education

• Degree in a relevant engineering or life science field.

Tools

• Familiarity with software development tools and documentation practices relevant to medical devices.