Hybrid R&D Software Design Control Specialist
agilent
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Benefits offered by this job
Job summary
Agilent is seeking an experienced R&D Software Design Control Specialist in Glostrup, Denmark, with hybrid work options (up to 2 days remote). You will strengthen software lifecycle engineering for pathology staining instruments in a regulated setting.
You will drive design control activities, ensure regulatory compliance, and collaborate across stakeholders to deliver safe, high-quality software for cancer diagnostics.
Qualifications
- Engineering degree in IT/Computer/Software or Life Science.
- Background in software with product development and sustaining/maintenance.
- Experience with design control in medical devices (IVD).
- Experience in a regulated environment (Medical Devices/Pharma).
- Excellent English communication skills.
- Knowledge of IEC 62304 and ISO 14971; Agile experience.
Responsibilities
- Execute software design control activities per Agilent Quality Management System.
- Ensure pathology software products comply with regulatory requirements.
- Contribute to DHF/Design History File and regulatory documentation.
- Translate user needs into product requirements and user stories.
- Perform software and cybersecurity risk assessments for safety/effectiveness.
- Collaborate with Test and Validation for design verification/validation.
Skills
Education
Tools
Job description
Agilent is seeking an experienced R&D Software Design Control Specialist in Glostrup, Denmark, with hybrid work options (up to 2 days remote). You will strengthen software lifecycle engineering for pathology staining instruments in a regulated setting.
You will drive design control activities, ensure regulatory compliance, and collaborate across stakeholders to deliver safe, high-quality software for cancer diagnostics.
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