R&D Software Design Control Specialist - Medical Devices

Job Description Want to go further in Research & Development for Medical Devices and IVDs? Here's where you take the next step, working with the pioneering teams taking Agilent's world-leading products from the drawing board to the real world. We are seeking a temporary R&D Software Design Control Specialist for our s oftware team in Glostrup , Denmark which is part of Pathology R&D in o ur Clinical Diagnostics Division . We want to strengthen our software Lifecycle engineering activities to ensure efficient and successful progress in new and sustain software projects for our high-quality portfolio of p athology staining i nstruments software for cancer diagnostics. The j ob and y our r esponsibilities: As R&D Software Design Control specialist, you will work with the team to drive activities and projects related to our software portfolio : Software improvement projects/activities e.g., feature enhancements and design optimizations based on customer feedback Software innovation projects e.g. new product introductions Software product care/sustaining activities Design Control and design documentation This position is based in Glostrup (Copenhagen), where partial remote work would be an option (up to 2 days a week). Your t ask s will include: E xecut ion o f 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 d ocumentation according to internal and regulatory requirements . Analyze and convert User needs to product requirements and user stories Conduct software and cybersecurity r isk a ssessment for safety and effectiveness of the product C ollab orate with Test and Validation responsible for design verification and validation ex ecut ion . 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 Qualifications Ideally a n engineering u niversity degree in IT/Computer/Software or a Life Science field A background in s oftware with knowledge in product development and sustaining/maintenance . E xperience with design control incl uding requirements engineering , design verification , change control , product risk management , Defect management and documentation with medical devices (IVD) .</sp