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 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 development opportunities
• Company pension scheme, individual bonus plan, private health care, medical & life insurance.
• A position within an international organization, offering a dynamic working environment, with exciting challenges and opportunities

Questions: For any questions, please contact the hiring manager, Jens Ole Madsen via email at Jens-Ole.Madsen@agilent.com . Application: We will review applications continuously so please send us your CV and cover letter as soon as possible via our recruitment system. We are looking forward to hearing from you. Additional Details This job has a full time weekly schedule. 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. Travel Required: Occasional Shift: Day Duration: Over 12 Months Job Function: R&D