MedTech Software Design & Compliance Specialist
DK05 DAKO Denmark R&D & Manufacturing
Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.
Benefits offered by this job
Job summary
Agilent Technologies Inc. is seeking a temporary R&D Software Design Control Specialist in Glostrup, Denmark, to strengthen software lifecycle engineering for pathology software in the Clinical Diagnostics Division.
You will translate user needs into product requirements, manage design control documentation, and ensure regulatory compliance. You will collaborate with cross-functional teams, participate in risk assessments, and support verification and validation activities in a regulated
Qualifications
- Engineering degree in IT/Computer/Software or Life Science
- Experience in software with product development and maintenance
- Design control experience for medical devices (IVD)
- Experience in regulated environments (medical devices, pharma)
- Strong English communication skills
- Familiarity with medical standards IEC 62304 and ISO 14971
- Preferably experience with Agile software development
Responsibilities
- Execute software design control activities per Agilent Quality Management System
- Ensure pathology software products meet regulatory requirements
- Contribute to the DHF/ DDF documentation and regulatory compliance
- Translate user needs into product requirements and user stories
- Perform software and cybersecurity risk assessments
- Collaborate with test and validation for design verification and validation
Skills
Education
Job description
Agilent Technologies Inc. is seeking a temporary R&D Software Design Control Specialist in Glostrup, Denmark, to strengthen software lifecycle engineering for pathology software in the Clinical Diagnostics Division.
You will translate user needs into product requirements, manage design control documentation, and ensure regulatory compliance. You will collaborate with cross-functional teams, participate in risk assessments, and support verification and validation activities in a regulated
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
