R&D Software Design Control Specialist – Medical Devices

Agilent Technologies; Glostrup Kommune; Hybrid; DKK 520,000 - 750,000; Full time

Benefits offered by this job

Outstanding company culture

Career development opportunities

Company pension scheme

Individual bonus plan

Private health care

Medical & life insurance

Job summary

Agilent Technologies in Glostrup, Denmark is seeking an R&D Software Design Control Specialist to drive design control activities for pathology software. You will ensure regulatory compliance and contribute to DHF/documentation while collaborating across departments.

The role requires a software background, experience in regulated environments, and strong English communication. Partial remote work up to 2 days a week is possible.

Qualifications

• Background in software with knowledge in product development and sustaining/maintenance.
• Experience with design control including requirements engineering, design verification, change control, product risk management, Defect management and documentation with medical devices (IVD).
• Experience from a regulated environment (Medical Devices, Pharma or similar).
• Excellent English verbal/written communications skills.
• Preferably knowledge of IEC 62304 and ISO 14971.
• Preferably experience with Agile software development.

Responsibilities

• Execution of software design control activities adhering to Agilent Quality Management System.
• Ensuring that Agilent’s pathology software products are in compliance with regulatory requirements.
• Contribute to the product DHF (DHF) and documentation according to internal and regulatory requirements.
• Analyze and convert User needs to product requirements and user stories.
• Conduct software and cybersecurity risk assessment for safety and effectiveness of the product.
• Collaborate with Test and Validation responsible for design verification and validation execution.
• To succeed, you collaborate with a broad range of stakeholders in the organization e.g. Marketing, Procurement, Regulatory Affairs, Quality Assurance, Manufacturing, Developers, Global Service, Usability and solution specialists

Skills

Background in software

Software product development

Agile software development

Excellent English communication

Education

Engineering university degree in IT/Computer/Software or Life Science

Job description

Agilent Technologies in Glostrup, Denmark is seeking an R&D Software Design Control Specialist to drive design control activities for pathology software. You will ensure regulatory compliance and contribute to DHF/documentation while collaborating across departments.

The role requires a software background, experience in regulated environments, and strong English communication. Partial remote work up to 2 days a week is possible.