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 software team in Glostrup, Denmark which is part of Pathology R&D in our 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 pathology staining instruments software for cancer diagnostics.
The job and your responsibilities:
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 tasks will include:
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
Qualifications
Ideally 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.
Preferably Knowledge of medical standards (IEC 62304 and ISO 14971)
Preferably experience with Agile software development
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 team, 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 accompa