R&D Software Design Control Specialist - Medical Devices

at  Agilent Technologies Inc

JOB DESCRIPTION

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the world around us. Information about Agilent is available at agilent.com.

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 an R&D Software Design Control Specialist for our software team in Glostrup, Denmark which is part of Pathology R&D in our Diagnostics and Genomics Group. We want to strengthen our software Lifecycle engineering activities to ensure efficient and successful progress in new or sustain software projects and maintenance of our high-quality portfolio of pathology staining instruments software for cancer diagnostics. As R&D Software Design Control Specialist, you will work with the team to accomplish activities and projects related to our software portfolio including software improvement projects/activities (such as feature enhancements and design optimizations based on customer feedback), software product care/sustaining activities as well as design control & documentation.

QUALIFICATIONS

We are looking for a motivated individual with the following background:

• Ideally an engineering university degree in IT/Computer/Software, with a background in product development and sustaining/maintenance
• Experience with design control including requirements engineering, design verification, change control, product risk management, defect management and documentation
• Experience in a regulated environment such as medical devices, pharma or similar would be a strong advantage
• Knowledge of medical standards IEC62304 is a plus
• Knowledge of / experience with Agile software development would be an asset
• Full proficiency in English. Proficiency in Danish would be a plus but is not a requirement

On a personal level, you can drive your activities while communicating and coordinating with various external and internal partners. 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 also 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.

• Execute software design control activities adhering to Agilent Quality Management System (QMS)
• Ensure Agilent’s pathology software products are in compliance with regulatory requirements
• Contribute to the product DHF and documentation according to internal and regulatory requirements
• Analyze and convert user needs to product requirements and user stories
• Conduct software risk assessment for safety and effectiveness of the product
• Collaborate with Test & Validation responsible for design verification and validation execution.
• Collaborate with a broad range of stakeholders in the organization like Marketing, Procurement, Regulatory Affairs, Quality Assurance, Manufacturing, Developers and Global Service, Usability & Solution.
  This is a temporary contract of 2 years based in Glostrup (Copenhagen), where partial remote work would be an option (up to 2 days a week).