Software Design Controls Specialist, Medical Devices R&D

Agilent; Denmark; Hybrid; DKK 600,000 - 900,000; Full time

Benefits offered by this job

Pension plan

Private health care

Career development

Job summary

Agilent seeks an R&D Software Design Control Specialist in Glostrup, Denmark, to drive design controls for pathology software used in cancer diagnostics. You will ensure regulatory compliance and contribute to DHF/DDF documentation, working with cross-functional teams and external stakeholders.

Ideal candidates hold an engineering degree with experience in software within a regulated medical device environment, familiarity with IEC 62304, and strong English communication.

Qualifications

• Engineering degree in IT/Computer/Software or Life Science.
• Experience in software development in a regulated medical device environment.
• Knowledge of design controls: requirements, verification, change control, risk management and documentation.
• IEC 62304 / ISO 14971 knowledge preferred.
• Excellent English communication skills.

Responsibilities

• Drive software design control activities per Agilent QMS.
• Ensure pathology software products meet regulatory requirements.
• Contribute to product documentation (DDF/DHF) and regulatory filings.
• Translate user needs into product requirements and user stories.
• Collaborate with test/validation teams on design verification and validation.
• Coordinate with stakeholders across Marketing, Regulatory, Quality, Manufacturing and Development.

Skills

Design control

Regulatory knowledge

Agile methodologies

Stakeholder communication

Education

Engineering degree IT/Computer/Software or Life Science

Job description

Agilent seeks an R&D Software Design Control Specialist in Glostrup, Denmark, to drive design controls for pathology software used in cancer diagnostics. You will ensure regulatory compliance and contribute to DHF/DDF documentation, working with cross-functional teams and external stakeholders.

Ideal candidates hold an engineering degree with experience in software within a regulated medical device environment, familiarity with IEC 62304, and strong English communication.