Remote Medical Device Software Design Control Specialist

DAKO Denmark R&D & Manufacturing; Glostrup Kommune; Hybrid; DKK 700,000 - 900,000; Full time

Benefits offered by this job

Company culture

Career development

Pension plan

Private health care

Medical & life insurance

Job summary

Agilent Technologies Inc. in Glostrup, Denmark, is seeking a temporary R&D Software Design Control Specialist to strengthen software lifecycle engineering for pathology R&D.

You will transform user needs into detailed product requirements, lead design control activities, and ensure compliance with regulatory standards. The role involves risk assessment, collaboration with verification/validation teams, and contributing to documentation across the DHF.

Qualifications

• Engineering degree in IT/Computer/Software or Life Science.
• Experience with design control in medical devices (IVD).
• Experience in a regulated environment (medical devices, pharma or similar).
• Excellent English communication skills and Agile software development familiarity.
• Knowledge of IEC 62304 and ISO 14971 preferred.

Responsibilities

• Drive software design control activities in line with regulatory requirements.
• Contribute to DHF/ DDF documentation and product requirements derivation.
• Assess software and cybersecurity risks for safety and effectiveness.
• Collaborate with test and validation teams for verification/validation.

Skills

Design control

Requirements engineering

Design verification

Change control

Risk management

Regulatory compliance

Agile development

Communication

Education

Engineering degree IT/Computer/Software or Life Science

Tools

IEC 62304

ISO 14971

Job description

Agilent Technologies Inc. in Glostrup, Denmark, is seeking a temporary R&D Software Design Control Specialist to strengthen software lifecycle engineering for pathology R&D.

You will transform user needs into detailed product requirements, lead design control activities, and ensure compliance with regulatory standards. The role involves risk assessment, collaboration with verification/validation teams, and contributing to documentation across the DHF.