R&D Software Design Control Specialist - Medical Devices

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) .   E xperience   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 devel opm ent   On a personal level you must be good at   driving your activities while   communicating   and coordinating with various stakeholders within   and external to   the organization . You are   dedicated and   driven by   results, which you reach by working   closely   with   your colleagues within   the tea m, as well as the rest of the organization.   You are well-structured and have a systematic way of working,   seeking   simple and effective solutions within the complexity that surrounds a medical device and the accompanying documentation package. You   can   work with day-to-day deadlines   and changing priorities,   as well as   in   projects with longer duration.      We offer:     •    Outstanding company culture   •    Career