Medical Device Software Design & Compliance Specialist

Agilent Technologies, Inc.; Denmark; Remote; DKK 700,000 - 900,000; Full time

Benefits offered by this job

Outstanding company culture

Career development opportunities

Pension scheme and private health care

Job summary

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

You will drive design control activities, translate user needs into product requirements, and ensure regulatory compliance across the software lifecycle. You will collaborate with Marketing, Regulatory Affairs, QA, Manufacturing and developers, balancing deadlines with quality.

Qualifications

• Ideally an engineering university degree in IT/Computer/Software or a Life Science field.
• 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. Ex. Medical Devices, Pharma or similar.
• Excellent English verbal/written communications skills.
• Preferably Knowledge of medical standards (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 DDF (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

Regulatory compliance

English communication

Design control methods

Education

Engineering degree IT/Computer/Software or Life Science

Job description

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

You will drive design control activities, translate user needs into product requirements, and ensure regulatory compliance across the software lifecycle. You will collaborate with Marketing, Regulatory Affairs, QA, Manufacturing and developers, balancing deadlines with quality.