Agilent is seeking a temporary R&D Software Design Control Specialist to support software lifecycle engineering for pathology staining instruments used in cancer diagnostics. This role ensures compliance with regulatory standards and drives design control activities within the Clinical Diagnostics Division in Glostrup, Denmark.
What You'll Do
- 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 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
- Collaborate with a broad range of stakeholders in the organization e.g. Marketing, Procurement, Regulatory Affairs, Quality Assurance, Manufacturing, Developers and Global Service, Usability and solution specialists
What We're Looking For
- Ideal candidates will hold an engineering university degree in IT/Computer/Software or a Life Science field
- A 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
Nice to Have
- Preferably Knowledge of medical standards (IEC 62304 and ISO 14971)
- Preferably experience with Agile software development
Technical Stack
- IEC 62304
- ISO 14971
- Agile software development
Team & Environment
- Part of Pathology R&D in Clinical Diagnostics Division
Benefits & Compensation
- Outstanding company culture
- Career development opportunities
- Company pension scheme
- Individual bonus plan
- Private health care
- Medical & life insurance
- Dynamic working environment
- Exciting challenges and opportunities
Work Mode
- Hybrid work model
- Based in Glostrup, Denmark
- Up to 2 days a week remote work possible
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
